Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2025-12-29 @ 5:05 PM
Study NCT ID:
NCT01485861
Status:
COMPLETED
Last Update Posted:
2023-09-14
First Post:
2011-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C089740', 'term': 'abiraterone'}, {'id': 'C583616', 'term': 'ipatasertib'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 10.7 years)', 'description': 'The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment. All-cause mortality is based on the ITT Population, which was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 82, 'seriousNumAtRisk': 84, 'deathsNumAffected': 67, 'seriousNumAffected': 43}, {'id': 'EG003', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 86, 'otherNumAffected': 79, 'seriousNumAtRisk': 88, 'deathsNumAffected': 71, 'seriousNumAffected': 42}, {'id': 'EG004', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 83, 'otherNumAffected': 76, 'seriousNumAtRisk': 81, 'deathsNumAffected': 68, 'seriousNumAffected': 18}, {'id': 'EG005', 'title': 'Safety Cohort: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 2, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 25, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 37, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'VISION BLURRED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ABDOMINAL PAIN LOWER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'CHEILOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 22, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 198, 'numAffected': 65}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 72, 'numAffected': 42}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 36, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 63, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ERUCTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 74, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 44, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 30, 'numAffected': 21}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 24, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ORAL DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'RETCHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'TONGUE DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 42, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 69, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 24, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 12, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 36, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 37, 'numAffected': 25}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'GAIT DISTURBANCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'MUCOSAL INFLAMMATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 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'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'RASH MACULO-PAPULAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'TOXIC SKIN ERUPTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'AORTIC ANEURYSM RUPTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'PELVIC VENOUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'MULTIPLE FRACTURES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'MALNUTRITION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}, {'term': 'DECUBITUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA18.1/23.1/25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 28 of Cycle 1 (Cycle length = 28 days)', 'description': 'DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than \\[\\<\\] 500 per microliter) lasting greater than (\\>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for \\> 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase Ib: Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).', 'description': 'An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Ipatasertib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}, {'title': 'Apitolisib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Based on safety analysis further testing of apitolisib arm was discontinued.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 1 to 28 of Cycle 1 (Cycle length = 28 days)', 'description': 'RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.', 'unitOfMeasure': 'milligrams (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment on Day 1 of Cycle 1.'}, {'type': 'PRIMARY', 'title': 'Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.18', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '10.87'}, {'value': '8.31', 'groupId': 'OG001', 'lowerLimit': '6.44', 'upperLimit': '10.48'}, {'value': '6.37', 'groupId': 'OG002', 'lowerLimit': '4.60', 'upperLimit': '8.34'}]}]}], 'analyses': [{'pValue': '0.1606', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.04', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.5300', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.20', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.1689', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Strata are: prior enzalutamide (Yes vs. No), progression factor (prostate-specific antigen \\[PSA\\] only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).'}, {'pValue': '0.7484', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Strata are: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (\\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'PRIMARY', 'title': 'Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.53', 'groupId': 'OG000', 'lowerLimit': '6.67', 'upperLimit': '13.73'}, {'value': '11.10', 'groupId': 'OG001', 'lowerLimit': '6.34', 'upperLimit': '16.36'}, {'value': '4.60', 'groupId': 'OG002', 'lowerLimit': '4.40', 'upperLimit': '6.37'}]}]}], 'analyses': [{'pValue': '0.0064', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.39', 'ciLowerLimit': '0.22', 'ciUpperLimit': '0.70', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.0285', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.46', 'ciLowerLimit': '0.25', 'ciUpperLimit': '0.83', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (\\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '269', 'spread': '41.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '466', 'spread': '36.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.97', 'upperLimit': '4.05'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.02', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1710', 'spread': '54.7', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 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[{'measurements': [{'value': '190', 'spread': '35.2', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1, Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once 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'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'unitOfMeasure': 'ng/mL*hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase Ib: 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(cycle length = 28 days)', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and 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Survival (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.27', 'groupId': 'OG000', 'lowerLimit': '16.66', 'upperLimit': '24.21'}, {'value': '17.31', 'groupId': 'OG001', 'lowerLimit': '13.83', 'upperLimit': '22.41'}, {'value': '18.37', 'groupId': 'OG002', 'lowerLimit': '13.80', 'upperLimit': '20.96'}]}]}], 'analyses': [{'pValue': '0.4170', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.22', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.6712', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.30', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.5164', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.27', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8955', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.44', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)', 'description': 'Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Overall Survival in Participants With ICR IHC PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.12', 'groupId': 'OG000', 'lowerLimit': '12.32', 'upperLimit': '28.02'}, {'value': '28.45', 'groupId': 'OG001', 'lowerLimit': '13.24', 'upperLimit': '33.28'}, {'value': '17.28', 'groupId': 'OG002', 'lowerLimit': '11.30', 'upperLimit': '20.96'}]}]}], 'analyses': [{'pValue': '0.1472', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.33', 'ciUpperLimit': '1.19', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '0.0157', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.23', 'ciUpperLimit': '0.87', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)', 'description': 'Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With PSA Progression (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '69.8', 'groupId': 'OG001'}, {'value': '72.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000'}, {'value': '64.0', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to PSA Progression (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'spread': '4.17', 'groupId': 'OG000', 'lowerLimit': '4.17', 'upperLimit': '7.39'}, {'value': '3.78', 'spread': '2.79', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': '5.49'}, {'value': '3.71', 'spread': '2.79', 'groupId': 'OG002', 'lowerLimit': '2.79', 'upperLimit': '4.67'}]}]}], 'analyses': [{'pValue': '= 0.0665', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.70', 'ciLowerLimit': '0.51', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9319', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.33', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.0710', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.70', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.97', 'groupDescription': 'Strata were: prior Enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7890', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.95', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.31', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to PSA Progression in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.71', 'spread': '2.99', 'groupId': 'OG000', 'lowerLimit': '2.99', 'upperLimit': '8.18'}, {'value': '2.92', 'spread': '2.07', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '7.39'}, {'value': '2.79', 'spread': '1.02', 'groupId': 'OG002', 'lowerLimit': '1.02', 'upperLimit': '4.67'}]}]}], 'analyses': [{'pValue': '= 0.2906', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.68', 'ciLowerLimit': '0.37', 'ciUpperLimit': '1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.2716', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.65', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.22', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'Months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With PSA Response (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'groupId': 'OG000', 'lowerLimit': '28.11', 'upperLimit': '46.40'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '25.29', 'upperLimit': '42.93'}, {'value': '34.9', 'groupId': 'OG002', 'lowerLimit': '26.25', 'upperLimit': '43.75'}]}]}], 'analyses': [{'pValue': '= 0.7913', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.97', 'ciLowerLimit': '-10.25', 'ciUpperLimit': '14.18', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '= 0.8675', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.22', 'ciLowerLimit': '-13.24', 'ciUpperLimit': '10.80', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)', 'description': 'PSA response was defined as a \\> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '24.57', 'upperLimit': '58.32'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '26.99', 'upperLimit': '61.06'}, {'value': '28.6', 'groupId': 'OG002', 'lowerLimit': '13.24', 'upperLimit': '46.41'}]}]}], 'analyses': [{'pValue': '= 0.4176', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '11.43', 'ciLowerLimit': '-11.43', 'ciUpperLimit': '58.32', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.2802', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.43', 'ciLowerLimit': '-7.58', 'ciUpperLimit': '38.44', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)', 'description': 'PSA response was defined as a \\> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Objective Response (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '20.56', 'groupId': 'OG000', 'lowerLimit': '20.56', 'upperLimit': '46.41'}, {'value': '23.1', 'spread': '13.69', 'groupId': 'OG001', 'lowerLimit': '13.69', 'upperLimit': '35.63'}, {'value': '22.9', 'spread': '11.91', 'groupId': 'OG002', 'lowerLimit': '11.91', 'upperLimit': '36.46'}]}]}], 'analyses': [{'pValue': '= 0.3646', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.58', 'ciLowerLimit': '-7.65', 'ciUpperLimit': '26.80', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.9821', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.22', 'ciLowerLimit': '-15.89', 'ciUpperLimit': '16.33', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '1.16', 'upperLimit': '39.09'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '12.18', 'upperLimit': '50.00'}, {'value': '14.3', 'groupId': 'OG002', 'lowerLimit': '1.49', 'upperLimit': '50.00'}]}]}], 'analyses': [{'pValue': '= 0.8489', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-3.17', 'ciLowerLimit': '-30.93', 'ciUpperLimit': '24.58', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.5186', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.38', 'ciLowerLimit': '-16.36', 'ciUpperLimit': '41.12', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for participants included in the actual analysis.'}, {'type': 'SECONDARY', 'title': 'Phase II: Duration of Tumor Response (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.77', 'comment': 'Data was not evaluable due to an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '3.75', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not evaluable due to an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '6.47', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data was not evaluable due to an insufficient number of events.', 'groupId': 'OG002', 'lowerLimit': '2.76', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.6780', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.31', 'ciLowerLimit': '0.45', 'ciUpperLimit': '3.80', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '= 0.8372', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.85', 'ciLowerLimit': '0.24', 'ciUpperLimit': '3.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '= 0.7733', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.17', 'ciUpperLimit': '3.50', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.4227', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.46', 'ciLowerLimit': '0.36', 'ciUpperLimit': '16.59', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants who had achieved an objective response.'}, {'type': 'SECONDARY', 'title': 'Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.77', 'comment': 'NA = Not estimable due to limited number of events observed', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to limited number of events observed', 'groupId': 'OG001', 'lowerLimit': '0.99', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Not estimable due to limited number of events observed', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.3173', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '999.99', 'ciLowerLimit': '0.00', 'estimateComment': '\\>', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'ciUpperLimitComment': 'NA = Not estimable due to limited number of events observed'}, {'pValue': '= 0.6171', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '999.99', 'ciLowerLimit': '0.00', 'estimateComment': '\\>', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'ciUpperLimitComment': 'NA = Not estimable due to limited number of events observed'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '56.44', 'upperLimit': '77.37'}, {'value': '71.0', 'groupId': 'OG001', 'lowerLimit': '61.07', 'upperLimit': '80.32'}, {'value': '63.5', 'groupId': 'OG002', 'lowerLimit': '52.41', 'upperLimit': '73.60'}]}]}], 'analyses': [{'pValue': '= 0.6652', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.75', 'ciLowerLimit': '-10.47', 'ciUpperLimit': '17.97', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.3734', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.48', 'ciLowerLimit': '-6.29', 'ciUpperLimit': '21.24', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC \\> 0 cells/7.5 milliliters (mL) at baseline.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '55.80', 'upperLimit': '87.42'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '55.80', 'upperLimit': '87.42'}, {'value': '70.6', 'groupId': 'OG002', 'lowerLimit': '50.00', 'upperLimit': '85.95'}]}]}], 'analyses': [{'pValue': '= 0.7633', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.41', 'ciLowerLimit': '-19.76', 'ciUpperLimit': '28.58', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7633', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.41', 'ciLowerLimit': '-19.76', 'ciUpperLimit': '28.58', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC \\> 0 cells/7.5 milliliters (mL) at baseline.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CTC Conversion (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '31.18', 'groupId': 'OG000', 'lowerLimit': '31.18', 'upperLimit': '57.87'}, {'value': '46.8', 'spread': '34.48', 'groupId': 'OG001', 'lowerLimit': '34.48', 'upperLimit': '59.72'}, {'value': '41.7', 'spread': '29.59', 'groupId': 'OG002', 'lowerLimit': '29.59', 'upperLimit': '54.55'}]}]}], 'analyses': [{'pValue': '= 0.8317', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.24', 'ciLowerLimit': '-15.07', 'ciUpperLimit': '19.54', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.6139', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.14', 'ciLowerLimit': '-11.60', 'ciUpperLimit': '21.88', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC conversion was defined as a decline to \\< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation. Data presented below is only for participants with CTC \\> 0 cells/7.5 milliliters (mL) at baseline.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '39.84', 'upperLimit': '84.58'}, {'value': '22.2', 'groupId': 'OG001', 'lowerLimit': '10.06', 'upperLimit': '41.88'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '18.11', 'upperLimit': '50.00'}]}]}], 'analyses': [{'pValue': '= 0.0505', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '34.85', 'ciLowerLimit': '7.14', 'ciUpperLimit': '62.56', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.4989', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in response rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.60', 'ciLowerLimit': '-32.54', 'ciUpperLimit': '13.35', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC conversion was defined as a decline to \\< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours. Data presented below is only for PTEN loss participants with CTC \\> 0 cells/7.5 milliliters (mL) at baseline.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Pain Progression (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '34.9', 'groupId': 'OG001'}, {'value': '34.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to Pain Progression (ITT Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.90', 'comment': 'Data was not evaluable because of an insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '8.61', 'upperLimit': 'NA'}, {'value': '16.16', 'comment': 'Data was not evaluable because of an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '8.54', 'upperLimit': 'NA'}, {'value': '15.15', 'comment': 'Data was not evaluable because of an insufficient number of events.', 'groupId': 'OG002', 'lowerLimit': '11.07', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.8483', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.95', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.47', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '= 0.7850', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.65', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Unstratified'}, {'pValue': '= 0.8847', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.04', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.65', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.8647', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.05', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.63', 'groupDescription': 'Strata were: prior enzalutamide (Yes vs. No), progression factor (PSA only vs. other), and number of prior chemotherapy regimens for metastatic disease (one vs. more than one).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Population was defined as all randomised participants with the participants allocated to the treatment arm according to the randomisation.'}, {'type': 'SECONDARY', 'title': 'Phase II: Time to Pain Progression in Participants With ICR PTEN Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.49', 'groupId': 'OG000', 'lowerLimit': '7.59', 'upperLimit': '16.49'}, {'value': 'NA', 'comment': 'Data was not evaluable because of an insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '8.28', 'upperLimit': 'NA'}, {'value': '6.93', 'comment': 'Data was not evaluable because of an insufficient number of events.', 'groupId': 'OG002', 'lowerLimit': '5.65', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '= 0.8271', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.39', 'ciUpperLimit': '2.06', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '= 0.7383', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '0.35', 'ciUpperLimit': '2.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The PTEN Loss population was defined as all randomised participants with PTEN loss tumours.'}, {'type': 'SECONDARY', 'title': 'Phase II: Percentage of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG002', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}, {'value': '96.6', 'groupId': 'OG001'}, {'value': '93.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)', 'description': 'An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population was defined as all participants who had received ipatasertib, apitolisib, placebo, or abiraterone treatment.'}, {'type': 'SECONDARY', 'title': 'Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1: 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '359.5', 'groupId': 'OG000'}, {'value': '63.4', 'spread': '187.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 1: 4 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '180', 'spread': '103.4', 'groupId': 'OG000'}, {'value': '87.0', 'spread': '71.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'spread': '97.2', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '61.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '213', 'spread': '174.3', 'groupId': 'OG000'}, {'value': '140', 'spread': '103.7', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: 4 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '272', 'spread': '137.9', 'groupId': 'OG000'}, {'value': '139', 'spread': '69.3', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1: predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.7', 'spread': '138.6', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '49.8', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2, Day 1: 1-4 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '243', 'spread': '94.4', 'groupId': 'OG000'}, {'value': '145', 'spread': '80.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.'}, {'type': 'SECONDARY', 'title': 'Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'OG001', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}], 'classes': [{'title': 'Cycle 1, Day 1: 1 hour postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.7', 'spread': '223.1', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '268.9', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 1: 4 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '101', 'spread': '61.8', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '96.6', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.1', 'spread': '92.4', 'groupId': 'OG000'}, {'value': '20.4', 'spread': '59.2', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: 2 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '121', 'spread': '159.4', 'groupId': 'OG000'}, {'value': '78.0', 'spread': '93.0', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1, Day 15: 4 hours postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '178', 'spread': '134.0', 'groupId': 'OG000'}, {'value': '101', 'spread': '61.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Pharmacokinetic (PK) Analysis Population was defined as all participants who had evaluable PK data. Data were only analyzed in ipatasertib treatment arms. Total number analyzed represents all participants with evaluations at one or more time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'FG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'FG002', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'FG003', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'FG004', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'FG005', 'title': 'Safety Cohort: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.'}], 'periods': [{'title': 'Phase Ib', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-To-Treat (ITT) population based on randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'comment': 'Based on treatment received', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progression of disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Phase II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '86'}, {'groupId': 'FG004', 'numSubjects': '83'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '84'}, {'groupId': 'FG003', 'numSubjects': '88'}, {'groupId': 'FG004', 'numSubjects': '81'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '83'}, {'groupId': 'FG003', 'numSubjects': '86'}, {'groupId': 'FG004', 'numSubjects': '83'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '68'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Progression of Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Study Ended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Safety Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Progression of Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'Discontinuation of Survival Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'The study was conducted at 55 centers in 10 countries.', 'preAssignmentDetails': 'The study consisted of 3 stages: Phase Ib determined recommended Phase II doses (RP2D) for ipatasertib and apitolisib in combination with abiraterone and prednisone/prednisolone. Phase II stage compared ipatasertib (400 mg or 200 mg daily) versus placebo each combined with abiraterone and prednisone/prednisolone. The third stage included the safety cohort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '298', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase Ib: Ipatasertib 400 mg', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'BG001', 'title': 'Phase Ib: Apitolisib 30 mg', 'description': 'Participants received apitolisib 30 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'BG002', 'title': 'Phase II: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'BG003', 'title': 'Phase II: Ipatasertib 200 mg + Abiraterone', 'description': 'Participants received ipatasertib 200 mg orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'BG004', 'title': 'Phase II: Placebo + Abiraterone', 'description': 'Participants received placebo (matched to ipatasertib 400 mg or 200) orally once daily, abiraterone 1000 mg orally once daily, and prednisone/prednisolone 5 mg orally bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.'}, {'id': 'BG005', 'title': 'Safety Cohort: Ipatasertib 400 mg + Abiraterone', 'description': 'Participants received ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '9.3', 'groupId': 'BG001'}, {'value': '66.9', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '68.8', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '67.6', 'spread': '7.8', 'groupId': 'BG004'}, {'value': '73.7', 'spread': '8.8', 'groupId': 'BG005'}, {'value': '68.3', 'spread': '8.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '298', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '244', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '263', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-To-Treat (ITT) Population included all participants allocated to the treatment arm according to randomization.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'In Phase II participants and investigators were blinded with regard to treatment status (i.e., ipatasertib vs. placebo). Phase Ib and the safety cohort were open-label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2011-12-02', 'resultsFirstSubmitDate': '2023-08-17', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-17', 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib: Percentage of Participants With Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'Days 1 to 28 of Cycle 1 (Cycle length = 28 days)', 'description': 'DLT: 1 of the following toxicities, at least possibly related to ipatasertib or apitolisib. 1) Grade ≥ 3 non-hematologic, non-hepatic major organ AE; 2) Grade ≥ 3 febrile neutropenia; 3) Grade ≥ 4 neutropenia (absolute neutrophils less than \\[\\<\\] 500 per microliter) lasting greater than (\\>) 7 days; 4) Grade ≥3 thrombocytopenia associated with acute hemorrhage; 5) Grade ≥4 thrombocytopenia; 6) Grade ≥4 anemia; 7) 1 episode of fasting Grade ≥4 hyperglycemia or 3 episodes of fasting Grade 3 hyperglycemia on separate days within 7 days, as determined by laboratory blood glucose evaluation; 8) Grade ≥3 elevation lasting for \\> 48 hours for hepatic transaminase or liver-specific alkaline phosphatase or total bilirubin. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.0.'}, {'measure': 'Phase Ib: Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 10 months).', 'description': 'An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Phase Ib: Recommended Phase II Dose (RP2D) of Ipatasertib and Apitolisib', 'timeFrame': 'Days 1 to 28 of Cycle 1 (Cycle length = 28 days)', 'description': 'RP2D is a dose of a drug which would be used in Phase II stage of the study. RP2D was to be determined based on maximum tolerated dose (MTD) in Phase Ib stage of the study. The highest dose level (in 3+3 escalation scheme) with an acceptable safety profile and with a minimum of 6 participants at which fewer than one-third of participants experienced a DLT was declared the MTD and RP2D.'}, {'measure': 'Phase II: Radiographic Progression Free Survival (rPFS) (Intent-To-Treat [ITT] Population)', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on a second bone scan ≥ 4 weeks later (\\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization).'}, {'measure': 'Phase II: rPFS in Participants With Institute of Cancer Research (ICR) Phosphatase and Tensin Homolog (PTEN) Loss', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'rPFS: Time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments via CT scan and bone scans, or death on study from any cause, whichever occurred first. Progression was defined as follows: Soft tissue mass (RECIST 1.1): at least 20% increase in sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions. Bone: ≥ 2 new bone lesions plus 2 additional at confirmation on 2nd bone scan ≥ 4 weeks later (\\< 12 weeks after randomization). ≥ 2 new bone lesions consistent with progression, without need for confirmatory bone scan (≥ 12 weeks after randomization). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss.'}], 'secondaryOutcomes': [{'measure': 'Phase Ib: Maximum Plasma Concentration (Cmax) of Ipatasertib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Time to Cmax (Tmax) of Ipatasertib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Area Under The Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24) of Ipatasertib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Total Body Clearance (CL/F) of Ipatasertib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 15 of Cycle 1 (cycle length = 28 days)', 'description': 'Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Phase Ib: Accumulation Ratio of Ipatasertib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).'}, {'measure': 'Phase Ib: Cmax of G-037720 (Metabolite of Ipatasertib)', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.'}, {'measure': 'Phase Ib: Tmax of G-037720 (Metabolite of Ipatasertib)', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.'}, {'measure': 'Phase Ib: AUC0-24 of G-037720 (Metabolite of Ipatasertib)', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.'}, {'measure': 'Phase Ib: Accumulation Ratio of G-037720 (Metabolite of Ipatasertib)', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation. Accumulation Ratio was calculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).'}, {'measure': 'Phase Ib: Cmax of Apitolisib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Tmax of Apitolisib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: AUC0-24 of Apitolisib When Co-Administered With Abiraterone', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Cmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Tmax of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: AUC0-24 of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Plasma Half-Life of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)'}, {'measure': 'Phase Ib: Accumulation Ratio of Abiraterone When Co-Administered With Ipatasertib or Apitolisib', 'timeFrame': 'Pre-dose (0 hour), 1, 2, 4, 6, 24 hours post dose on Days 1, 15 of Cycle 1 (cycle length = 28 days)', 'description': 'Accumulation Ratio was caculated as AUC0-24 (Cycle 1 Day 15) divided by AUC0-24 (Cycle 1 Day 1).'}, {'measure': 'Phase II: Overall Survival (ITT Population)', 'timeFrame': 'Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)', 'description': 'Overall survival was defined as the interval between the date of screening and death due to any cause. Overall survival was estimated using Kaplan Meier method.'}, {'measure': 'Phase II: Overall Survival in Participants With ICR IHC PTEN Loss', 'timeFrame': 'Screening up to death (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 8.9 years overall]) (cycle length = 28 days)', 'description': 'Overall survival was defined as the interval between the date of randomization and death from any cause. Overall survival was estimated using Kaplan Meier method. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With PSA Progression (ITT Population)', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 nanogram per milliliter (ng/mL) from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.'}, {'measure': 'Phase II: Percentage of Participants With PSA Progression in Participants With ICR PTEN Loss', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Time to PSA Progression (ITT Population)', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression is defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later.'}, {'measure': 'Phase II: Time to PSA Progression in Participants With ICR PTEN Loss', 'timeFrame': 'Screening up to PSA progression (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Time to PSA progression: Time from screening to the first occurrence of PSA progression, as determined by investigator. PSA progression was defined as per Prostate Cancer Working Group 2 criteria. PSA progression was defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the baseline value, or a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL from the nadir if PSA decreases from baseline after treatment, which was confirmed by a second value obtained ≥ 3 weeks later. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With PSA Response (ITT Population)', 'timeFrame': 'Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)', 'description': 'PSA response was defined as a \\> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement.'}, {'measure': 'Phase II: Percentage of Participants With PSA Response in Participants With ICR PTEN Loss', 'timeFrame': 'Baseline up to 30 days after last dose (assessed at baseline, Day 1 of every cycle [starting from Cycle 2] till 30 days after last dose [up to overall 3.6 years]) (cycle length = 28 days)', 'description': 'PSA response was defined as a \\> 50% decrease in PSA from baseline, which was to be confirmed after ≥ 4 weeks by a confirmatory PSA measurement. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With Objective Response (ITT Population)', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Objective response was defined as having a confirm response (CR) or partial response (PR) according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions.'}, {'measure': 'Phase II: Percentage of Participants With Objective Response in Participants With ICR PTEN Loss', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Objective response was defined as having a CR or PR according to a RECIST 1.1. CR was defined as disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum diameters), no progression in non-target lesions, and no new lesions. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss". Number of participants analyzed=participants with PTEN loss and evaluable for this endpoint.'}, {'measure': 'Phase II: Duration of Tumor Response (ITT Population)', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.'}, {'measure': 'Phase II: Duration of Tumor Response in Participants With ICR PTEN Loss', 'timeFrame': 'Screening up to radiographic progression or death, whichever occurred first (assessed at screening, after Cycles 3, 5, 7, 9, every three cycles [12 weeks] thereafter up to end of treatment [up to 3.6 years overall]) (cycle length = 28 days)', 'description': 'Duration of tumor response: time period from 1st documentation of objective response (CR/PR) (whichever status was recorded first) to date of 1st occurrence of investigator documented disease progression or death. CR: disappearance of all target and non-target lesions and no new lesions, all pathological lymph nodes must have decreased to \\<10 mm in short axis. PR: at least 30% decrease in sum of diameters of target lesions (taking as reference baseline sum diameters), no progression in non-target lesions, and no new lesions. Progression: increase by at least 20% in sum of longest diameters of each target lesion, taking as reference smallest sum of longest diameters or appearance of one or more new lesions. Duration of tumor response was estimated using Kaplan Meier method.'}, {'measure': 'Phase II: Percentage of Participants With Circulating Tumor Cells (CTC) Reduction Response (ITT Population)', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline.'}, {'measure': 'Phase II: Percentage of Participants With CTC Reduction Response in Participants With ICR PTEN Loss', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC reduction response was defined as participants with a reduction in CTCs of ≥ 30% compared to baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With CTC Conversion (ITT Population)', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC conversion was defined as a decline to \\< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline.'}, {'measure': 'Phase II: Percentage of Participants With CTC Conversion in Participants With ICR PTEN Loss', 'timeFrame': 'Baseline, on Day 1 of Cycle 2, on Day 1 of Cycle 3, and at the treatment completion visit (up to overall 3.6 years) (cycle length=28 days)', 'description': 'CTC conversion was defined as a decline to \\< 5 cells/7.5 milliliter (mL) post baseline among participants with CTC ≥ 5 cells/7.5 mL at baseline. PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With Pain Progression (ITT Population)', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).'}, {'measure': 'Phase II: Percentage of Participants With Pain Progression in Participants With ICR PTEN Loss', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Time to Pain Progression (ITT Population)', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression was defined as ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of four questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10).'}, {'measure': 'Phase II: Time to Pain Progression in Participants With ICR PTEN Loss', 'timeFrame': 'Screening, Day 1 of each cycle (cycle length=28 days) up to treatment completion (up to 3.6 years)', 'description': 'Time to pain progression was defined as the time from screening till first occurrence of pain progression. Pain progression: ≥ 2 point-increase from baseline on the modified Brief Pain Inventory - short form (mBPI-sf). The mBPI-sf consists of 4questions that assess pain intensity (worst, least, average, right now) and seven items within one question that assess the impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was assessed on 0-10 scale with 0 being no pain to 10 being worst imaginable pain. Total score was the average of individual item (range 0-10). PTEN status was assessed by RUO IHC assay that was performed at ICR, UK. Samples with 100% of the tumor with no PTEN staining were classified as "ICR PTEN loss".'}, {'measure': 'Phase II: Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up until 30 days following the last administration of study treatment or until initiation of another anti-cancer therapy, whichever occurred first (up to approximately 8.9 years)', 'description': 'An Adverse Event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Phase II: Ipatasertib Plasma Concentrations When Co-Administered With Abiraterone', 'timeFrame': 'Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)'}, {'measure': 'Phase II: G-037720 (Metabolite of Ipatasertib) Plasma Concentrations', 'timeFrame': 'Phase II: Cycle 1, Day 1: 1, 4 hours postdose; Cycle 1, Day 15: predose, 2, 4 hours postdose; Cycle 2, Day 1: predose, 1-4 hours postdose (cycle length = 28 days)', 'description': 'G-037220 is N-dealkylated metabolite of ipatasertib and the main metabolite in circulation.'}]}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed metastatic or advanced prostate adenocarcinoma that has been previously treated with docetaxel-based therapy and has progressed during treatment of at least one hormonal therapy(prior docetaxel is not required for the safety cohort)\n* Two rising PSA levels greater than or equal to (\\>/=) 2 ng/mL measured \\>/= 1 week apart or radiographic evidence of disease progression in soft tissue or bone\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening\n* Adequate hematologic and organ function\n* Documented willingness to use an effective means of contraception\n* Safety cohort only: agreement to use CGM for first cycle of treatment\n\nExclusion Criteria:\n\n* History of Type I or Type II diabetes mellitus requiring insulin; safety cohort: patients who are receiving any pharmacologic treatment for diabetes are not eligible\n* New York Heart Association Class III or IV heart failure or Left ventricular ejection fraction \\< 50% or ventricular arrhythmia requiring medication\n* Significant atherosclerotic disease, as evidenced by: unstable angina, history of myocardial infarction within 6 months prior to Day 1, or cerebrovascular accident within 6 months prior to Day 1\n* Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs or active inflammatory disease which requires immunosuppressive therapy\n* Clinically significant history of liver disease\n* History of adrenal insufficiency or hyperaldosteronism\n* Phase II only: Previous therapy for prostate cancer with 17 alpha-hydroxylase/C17,20-lyase inhibitors, including abiraterone\n* Phase II only: Previous treatment for prostate cancer with Protein kinase B phosphatidylinositol 3 kinase and/or mammalian target of rapamycin inhibitors\n* Need for chronic corticosteroid therapy of \\>/= 20 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressant'}, 'identificationModule': {'nctId': 'NCT01485861', 'briefTitle': 'Study of Ipatasertib or Apitolisib With Abiraterone Acetate Versus Abiraterone Acetate in Participants With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'GO27983'}, 'secondaryIdInfos': [{'id': '2011-004126-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Ipatasertib 400 mg + abiraterone', 'description': 'Participants will receive ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Ipatasertib', 'Drug: Prednisone', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase Ib: Apitolisib 30 mg + abiraterone', 'description': 'Participants will receive apitolisib 30 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg twice daily (bid) continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Apitolisib', 'Drug: Prednisone', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: Ipatasertib 400 mg + abiraterone', 'description': 'Participants will receive Ipatasertib 400 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Ipatasertib', 'Drug: Prednisone', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II: Ipatasertib 200 mg + abiraterone', 'description': 'Participants will receive Ipatasertib 200 mg once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Ipatasertib', 'Drug: Prednisone', 'Drug: Prednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase II: Placebo + abiraterone', 'description': 'Participants will receive placebo (for Ipatasertib) once daily, abiraterone 1000 mg once daily, and prednisone/prednisolone 5 mg bid continuously in 28-day treatment cycles until disease progression or intolerable toxicity.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Placebo', 'Drug: Prednisone', 'Drug: Prednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone', 'description': 'Participants will receive ipatasertib 400 mg orally once daily and/or prednisone/prednisolone 5 mg orally once daily or bid and/or abiraterone 1000 mg orally once daily according to the following schedule: ipatasertib in the morning during Cycle 1, Days 1-7; ipatasertib in the morning plus prednisone/prednisolone once at night during Cycle 1, Day 8; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) during Cycle 1, Days 9-11; ipatasertib in the morning plus prednisone/prednisolone bid (morning and night) and abiraterone in the morning during Cycle 1, Days 12-18; ipatasertib in the evening plus prednisone/prednisolone bid (morning and night) and abiraterone at the same time as ipatasertib during Cycle 1, Days 19-25; Cycle 2 and beyond ipatasertib once daily in the morning or evening, abiraterone at the same time as ipatasertib, and prednisone/prednisolone bid.', 'interventionNames': ['Drug: Abiraterone', 'Drug: Ipatasertib', 'Drug: Prednisone', 'Drug: Prednisolone']}], 'interventions': [{'name': 'Abiraterone', 'type': 'DRUG', 'description': 'Orally once daily', 'armGroupLabels': ['Phase II: Ipatasertib 200 mg + abiraterone', 'Phase II: Ipatasertib 400 mg + abiraterone', 'Phase II: Placebo + abiraterone', 'Phase Ib: Apitolisib 30 mg + abiraterone', 'Phase Ib: Ipatasertib 400 mg + abiraterone', 'Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone']}, {'name': 'Apitolisib', 'type': 'DRUG', 'description': 'Orally once daily', 'armGroupLabels': ['Phase Ib: Apitolisib 30 mg + abiraterone']}, {'name': 'Ipatasertib', 'type': 'DRUG', 'description': 'Orally once daily', 'armGroupLabels': ['Phase II: Ipatasertib 200 mg + abiraterone', 'Phase II: Ipatasertib 400 mg + abiraterone', 'Phase Ib: Ipatasertib 400 mg + abiraterone', 'Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Orally once daily', 'armGroupLabels': ['Phase II: Placebo + abiraterone']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Orally bid', 'armGroupLabels': ['Phase II: Ipatasertib 200 mg + abiraterone', 'Phase II: Ipatasertib 400 mg + abiraterone', 'Phase II: Placebo + abiraterone', 'Phase Ib: Apitolisib 30 mg + abiraterone', 'Phase Ib: Ipatasertib 400 mg + abiraterone', 'Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'Orally bid', 'armGroupLabels': ['Phase II: Ipatasertib 200 mg + abiraterone', 'Phase II: Ipatasertib 400 mg + abiraterone', 'Phase II: Placebo + abiraterone', 'Phase Ib: Apitolisib 30 mg + abiraterone', 'Phase Ib: Ipatasertib 400 mg + abiraterone', 'Safety Cohort: Ipataseritib 400 mg + Abiraterone + Prednisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Research Institute ? 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