Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-02-20 @ 8:09 PM
Study NCT ID:
NCT03770494
Status:
TERMINATED
Last Update Posted:
2025-11-04
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY3405105 in Participants With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'United Kingdom']}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Follow-up (Up To 690 Days)', 'description': 'All phase 1a participants who received at least one dose of LY3405105. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 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{'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Up To 28 Days)', 'description': "A DLT is a clinically significant adverse event that is possibly related to the study drug and fulfils any one of the following criteria using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0:\n\n1\\) Nonhematologic Grade ≥3 toxicity, except nausea, constipation, diarrhoea, vomiting or electrolyte disturbance lasting for \\<72 hours and can be controlled with treatment, fatigue/anorexia lasting for \\<5 days, transient grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), without evidence of other hepatic injury; 2) Total bilirubin \\>2×upper limit of normal (ULN) with ALT/AST \\>3×ULN in the absence of cholestasis (alkaline phosphatase \\<2×ULN); 3) Grade 4 neutropenia \\>5 days duration, Any febrile neutropenia, Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 3/4 anemia or any other significant toxicity deemed to be dose limiting by investigators.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All phase 1a participants who received at least one dose of LY3405105 in Cycle 1.'}, {'type': 'SECONDARY', 'title': 'Phase 1a (Part A1): Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY3405105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'spread': '63', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '140', 'groupId': 'OG001'}, {'value': '91.3', 'spread': '120', 'groupId': 'OG002'}, {'value': '102', 'spread': '24', 'groupId': 'OG003'}, {'value': '159', 'spread': '148', 'groupId': 'OG004'}, {'value': '775', 'spread': '24', 'groupId': 'OG005'}, {'value': '1730', 'spread': '104', 'groupId': 'OG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N=1, Geometric mean and coefficient of variation were not calculated. Individual value reported: 623 ng\\*h/mL.', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N=1, Geometric mean and coefficient of variation were not calculated. Individual value reported: 599 ng\\*h/mL.', 'groupId': 'OG008'}, {'value': '328', 'spread': '80', 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)', 'description': 'AUC(0-24) of LY3405105', 'unitOfMeasure': 'nanograms*hours per milliliter (ng*h/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All part A1 participants of phase 1a who received at least one dose of LY3405105 and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase 1a (Part A1): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.6', 'spread': '37', 'groupId': 'OG000'}, {'value': '47.4', 'spread': '115', 'groupId': 'OG001'}, {'value': '132', 'spread': '74', 'groupId': 'OG002'}, {'value': '153', 'spread': '46', 'groupId': 'OG003'}, {'value': '208', 'spread': '25', 'groupId': 'OG004'}, {'value': '1620', 'spread': '53', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N=2, Geometric mean and coefficient of variation were not calculated. Individual values reported: 1760 ng\\*h/mL, 3610 ng\\*h/mL', 'groupId': 'OG007'}, {'value': 'NA', 'spread': 'NA', 'comment': "Due to insufficient quantifiable data, AUC(Tau) couldn't be calculated for any of the participants.", 'groupId': 'OG009'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)', 'description': 'AUC of LY3405105 during one dosing interval of 24 hours \\[tau = 24 hours\\].', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All part A1 participants of phase 1a who received at least one dose of LY3405105 and had evaluable PK data. For Part A1 Cohort 7 (45 mg, QD) and Cohort 9 (25 mg, QD), day 15 PK data was not collected for any participants as study was terminated prior to data collection; thus, zero participants were analysed.'}, {'type': 'SECONDARY', 'title': 'Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3405105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '88', 'groupId': 'OG000'}, {'value': '63.3', 'spread': '48', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'N=2, Geometric mean and coefficient of variation were not calculated. Individual values reported: 73.9 ng\\*h/mL, 113 ng\\*h/mL', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)', 'description': 'AUC(0-∞) of LY3405105.', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All part A2 participants of phase 1a who received at least one dose of LY3405105 and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'spread': '81', 'groupId': 'OG000'}, {'value': '32.6', 'spread': '201', 'groupId': 'OG001'}, {'value': '163', 'spread': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)', 'description': 'AUC of LY3405105 during one dosing interval of 48 hours \\[tau = 48 hours\\].', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All part A2 participants of phase 1a who received at least one dose of LY3405105 and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase 1a: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Measured Progressive Disease (Up To 349 Days)', 'description': 'ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All phase 1a participants who received at least one dose of LY3405105.'}, {'type': 'SECONDARY', 'title': 'Phase 1a: Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), Confirmed CR or PR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '20', 'groupId': 'OG006'}, {'value': '66.7', 'groupId': 'OG007'}, {'value': '33.3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '50', 'groupId': 'OG010'}, {'value': '75', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Measured Progressive Disease (Up To 349 Days)', 'description': 'DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All phase 1a participants who received at least one dose of LY3405105.'}, {'type': 'SECONDARY', 'title': 'Phase 1a: Duration of Response (DOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'timeFrame': 'Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)', 'description': 'DoR will be calculated only for responders. It is measured from the date of first evidence of a confirmed CR or PR response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analysed. DoR was not evaluable as there were no participants with CR or PR.'}, {'type': 'SECONDARY', 'title': 'Phase 1a: Time to Response (TTR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'OG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}], 'timeFrame': 'Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)', 'description': 'TTR is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analysed. TTR was not evaluable as there were no participants with CR or PR.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b', 'description': 'This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types.'}], 'timeFrame': 'Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)', 'description': 'PFS is defined as the time from the date of start of treatment to the first date of radiologically documented progressive disease or the date of death due to any cause, whichever occurs first.', 'reportingStatus': 'POSTED', 'populationDescription': 'PFS is a phase 1b outcome measure. Phase 1b of the study is not conducted and no participant enrolled, thus no data collected.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b', 'description': 'This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types.'}], 'timeFrame': 'Baseline to Date of Death from Any Cause (Estimated up to 12 Months)', 'description': 'OS is defined as the time from the date of start of treatment to the date of death due to any cause.', 'reportingStatus': 'POSTED', 'populationDescription': 'OS is a phase 1b outcome measure. Phase 1b of the study is not conducted and no participant enrolled, thus no data collected.'}, {'type': 'PRIMARY', 'title': 'Phase 1b: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b', 'description': 'This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types.'}], 'timeFrame': 'Baseline through Measured Progressive Disease (Estimated up to 6 Months)', 'description': 'ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.', 'reportingStatus': 'POSTED', 'populationDescription': 'ORR is phase 1b primary outcome measure. Phase 1b of the study is not conducted and no participant enrolled, thus no data collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 three times per week (TIW) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'FG013', 'title': 'Phase 1b', 'description': 'This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Received At Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '4'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '3'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "* Phase 1a was a dose escalation phase with a starting dose of LY3405105 1 milligram (mg) once daily (Part A1) or 2 mg three times per week (Part A2) on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason. Each dose level will have minimum of 3 participants enrolled.\n* Phase 1b was a dose expansion phase which was planned but not initiated based on sponsor's decision and limited efficacy observed in phase 1a. No participants enrolled.", 'preAssignmentDetails': 'Completers included participants who died from any cause.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '4', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '54', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A1 Cohort 1 (1 mg, QD)', 'description': 'Participants received 1 mg LY3405105 once daily (QD) orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG001', 'title': 'Part A1 Cohort 2 (2 mg, QD)', 'description': 'Participants received 2 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG002', 'title': 'Part A1 Cohort 3 (4 mg, QD)', 'description': 'Participants received 3 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG003', 'title': 'Part A1 Cohort 4 (8 mg, QD)', 'description': 'Participants received 8 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG004', 'title': 'Part A1 Cohort 5 (15 mg, QD)', 'description': 'Participants received 15 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG005', 'title': 'Part A1 Cohort 6 (30 mg, QD)', 'description': 'Participants received 30 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG006', 'title': 'Part A1 Cohort 7 (45 mg, QD)', 'description': 'Participants received 45 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG007', 'title': 'Part A1 Cohort 8 (35 mg, QD)', 'description': 'Participants received 35 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG008', 'title': 'Part A1 Cohort 9 (25 mg, QD)', 'description': 'Participants received 25 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG009', 'title': 'Part A1 Cohort 10 (20 mg, QD)', 'description': 'Participants received 20 mg LY3405105 QD orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG010', 'title': 'Part A2 Cohort 1 (2 mg, TIW)', 'description': 'Participants received 2 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG011', 'title': 'Part A2 Cohort 2 (4 mg, TIW)', 'description': 'Participants received 4 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG012', 'title': 'Part A2 Cohort 3 (8 mg, TIW)', 'description': 'Participants received 8 mg LY3405105 TIW orally on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '4', 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'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Asian', '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'}, 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{'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '43', 'groupId': 'BG013'}]}, {'title': 'More than one race', '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'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '7', 'groupId': 'BG013'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '4', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '17', 'groupId': 'BG013'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '30', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants. Only phase 1a participants baseline characters reported as no participant enrolled in phase 1b.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-13', 'size': 1262953, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-11-11T07:51', 'hasProtocol': True}, {'date': '2020-07-20', 'size': 4129372, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-11-11T07:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'The study was terminated for lack of sufficient efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2018-12-07', 'resultsFirstSubmitDate': '2025-08-21', 'studyFirstSubmitQcDate': '2018-12-07', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-08', 'studyFirstPostDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1a: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 (Up To 28 Days)', 'description': "A DLT is a clinically significant adverse event that is possibly related to the study drug and fulfils any one of the following criteria using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.0:\n\n1\\) Nonhematologic Grade ≥3 toxicity, except nausea, constipation, diarrhoea, vomiting or electrolyte disturbance lasting for \\<72 hours and can be controlled with treatment, fatigue/anorexia lasting for \\<5 days, transient grade 3 elevations of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), without evidence of other hepatic injury; 2) Total bilirubin \\>2×upper limit of normal (ULN) with ALT/AST \\>3×ULN in the absence of cholestasis (alkaline phosphatase \\<2×ULN); 3) Grade 4 neutropenia \\>5 days duration, Any febrile neutropenia, Grade 4 thrombocytopenia of any duration, Grade 3 thrombocytopenia with clinically significant bleeding, Grade 3/4 anemia or any other significant toxicity deemed to be dose limiting by investigators."}, {'measure': 'Phase 1b: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline through Measured Progressive Disease (Estimated up to 6 Months)', 'description': 'ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.'}], 'secondaryOutcomes': [{'measure': 'Phase 1a (Part A1): Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY3405105', 'timeFrame': 'Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)', 'description': 'AUC(0-24) of LY3405105'}, {'measure': 'Phase 1a (Part A1): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105', 'timeFrame': 'Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24 hours post-dose)', 'description': 'AUC of LY3405105 during one dosing interval of 24 hours \\[tau = 24 hours\\].'}, {'measure': 'Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY3405105', 'timeFrame': 'Cycle 1 Day 1 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)', 'description': 'AUC(0-∞) of LY3405105.'}, {'measure': 'Phase 1a (Part A2): PK: Area Under the Concentration Versus Time Curve During One Dosing Interval [AUC(Tau)] of LY3405105', 'timeFrame': 'Cycle 1 Day 15 (Predose, 1, 2, 4, 6, 8, 24, 48 hours post-dose)', 'description': 'AUC of LY3405105 during one dosing interval of 48 hours \\[tau = 48 hours\\].'}, {'measure': 'Phase 1a: Objective Response Rate (ORR): Percentage of Participants With a Confirmed Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline through Measured Progressive Disease (Up To 349 Days)', 'description': 'ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.'}, {'measure': 'Phase 1a: Disease Control Rate (DCR): Percentage of Participants Who Exhibit Stable Disease (SD), Confirmed CR or PR', 'timeFrame': 'Baseline through Measured Progressive Disease (Up To 349 Days)', 'description': 'DCR is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.'}, {'measure': 'Phase 1a: Duration of Response (DOR)', 'timeFrame': 'Date of Confirmed CR or PR to Date of Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)', 'description': 'DoR will be calculated only for responders. It is measured from the date of first evidence of a confirmed CR or PR response to the date of first progression of disease or the date of death due to any cause, whichever is earlier.'}, {'measure': 'Phase 1a: Time to Response (TTR)', 'timeFrame': 'Baseline to Date of Confirmed CR or PR (Estimated up to 6 Months)', 'description': 'TTR is defined as the time from the date of start of treatment to the date measurement criteria for confirmed CR or PR (whichever is first recorded) are first met.'}, {'measure': 'Phase 1b: Progression Free Survival (PFS)', 'timeFrame': 'Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 12 Months)', 'description': 'PFS is defined as the time from the date of start of treatment to the first date of radiologically documented progressive disease or the date of death due to any cause, whichever occurs first.'}, {'measure': 'Phase 1b: Overall Survival (OS)', 'timeFrame': 'Baseline to Date of Death from Any Cause (Estimated up to 12 Months)', 'description': 'OS is defined as the time from the date of start of treatment to the date of death due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '37531083', 'type': 'DERIVED', 'citation': 'Garralda E, Schram AM, Bedard PL, Schwartz GK, Yuen E, McNeely SC, Ribeiro S, Cunningham J, Wang Y, Urunuela A, Xu X, LoRusso P. A Phase I Dose-Escalation Study of LY3405105, a Covalent Inhibitor of Cyclin-Dependent Kinase 7, Administered to Patients With Advanced Solid Tumors. Oncologist. 2024 Jan 5;29(1):e131-e140. doi: 10.1093/oncolo/oyad215.'}, {'pmid': '32385714', 'type': 'DERIVED', 'citation': 'Sava GP, Fan H, Coombes RC, Buluwela L, Ali S. CDK7 inhibitors as anticancer drugs. Cancer Metastasis Rev. 2020 Sep;39(3):805-823. doi: 10.1007/s10555-020-09885-8.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/ISkx1UpFmMIUiQYaemQSE', 'label': 'A Study of LY3405105 in Participants With Advanced Cancer'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate the safety of LY3405105 in participants with advanced cancer. The study has two parts phase 1a and phase 1b. Participants will only enroll in one part.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPhase 1 a:\n\n* Have histological or cytological evidence of a diagnosis of a solid tumor cancer that is advanced and/or metastatic\n* Have available archived tissue for exploratory biomarker analysis\n* Have adequate organ function\n* Have discontinued all previous treatments for cancer and recovered from their side effects\n* Are able to swallow capsules/tablets\n\nPhase 1 b:\n\n* Cohort 1: Triple-negative breast cancer (TNBC).\n* Cohort 2: Clear cell ovarian cancer, endometrioid ovarian cancer, or endometrioid endometrial carcinoma with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).\n* Cohort 3: Soft tissue sarcoma or sarcomatoid/rhabdoid malignancy with loss of expression of INI1, BRG1, or BRM by immunohistochemistry or a LOF mutation in one or more of the following genes: ARID1A, SMARCA2, SMARCA4, or SMARCB1. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 3. Participants with synovial sarcoma and a confirmed SS18-SSX gene fusion are also eligible.\n* Cohort 4: Epithelioid sarcoma with INI1 loss of expression by immunohistochemistry or SMARCB1 LOF mutation. Participants aged ≥ 12 years with a body weight of ≥ 40 kilogram (kg) are acceptable for Cohorts 4.\n* Cohort 5: Bladder cancer with a LOF mutation in one or more of the following genes: ARID1A, KMT2C (MLL3), KMT2D (MLL2), or KDM6A (UTX).\n\nExclusion Criteria:\n\n* Have symptomatic central nervous system (CNS) malignancy or metastasis\n* Have symptomatic human immunodeficiency virus (HIV), Hepatitis A, B, or C\n* Have congestive heart failure\n* Are breastfeeding'}, 'identificationModule': {'nctId': 'NCT03770494', 'briefTitle': 'A Study of LY3405105 in Participants With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1a/1b Study of LY3405105 Administered to Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '17125'}, 'secondaryIdInfos': [{'id': 'J1F-MC-JZFA', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2018-002668-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3405105', 'description': "This study was designed to be conducted in two phases:\n\nPhase 1a: This is a dose-escalation phase with a starting dose of LY3405105 1 milligram (mg) once daily (Part A1) or 2 mg three times per week (Part A2) on a 28-day cycle until confirmed progressive disease, unacceptable toxicity, or discontinuation for any other reason. Each dose-level will be determined and will have participants enrolled to it based on dose-limiting toxicity rate observed at previous dose-level. Intermediate, alternate, or higher dose levels will be explored if deemed necessary.\n\nPhase 1b: This is a dose-expansion phase designed to explore the anti-tumor activity of recommended LY3405105 dose and dosing schedule determined in phase 1a, in participants with multiple tumor types.\n\n\\[Phase 1b was planned but not initiated based on the sponsor's decision and limited efficacy observed in phase 1a\\]", 'interventionNames': ['Drug: LY3405105']}], 'interventions': [{'name': 'LY3405105', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['LY3405105']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Smilow Cancer Hospital at Yale-New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'M5TY 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '75248', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Madrid Norte Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '704', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng-Kung Uni. Hosp.', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}