Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2026-02-10 @ 8:49 AM
Study NCT ID:
NCT01663857
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study LY2228820 for Recurrent Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['India']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C580958', 'term': 'ralimetinib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinicaltrials.gov@lilly.com', 'phone': '800-575-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 4.5 years', 'description': 'All participants who received at least one dose of drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Cohort 1: LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)\n\nGemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10\n\nCarboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nCohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nCohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 58, 'seriousNumAtRisk': 58, 'deathsNumAffected': 30, 'seriousNumAffected': 26}, {'id': 'EG003', 'title': 'Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 52, 'seriousNumAtRisk': 52, 'deathsNumAffected': 31, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 91, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 73, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 72, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 74, 'numAffected': 26}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 40, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 47, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 40, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 18, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 50, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 11, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 50, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 48, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2228820 + Gemcitabine + Carboplatin', 'description': 'Cohort 1 : LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6)\n\nGemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10\n\nCarboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nCohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3\n\nCohort 1 and 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycle 1 (21 Days)', 'description': 'Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).', 'unitOfMeasure': 'milligrams (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Phase 1b.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2228820 + Gemcitabine +Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of 21-day cycles.\n\nGemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of 21-day cycles.\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)'}, {'id': 'OG001', 'title': 'Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of 21-day cycles.\n\nGemcitabine 1000 mg/m2 IV over 30 min on Days 3 and 10 of 21-day cycles.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. n Day 3 of 21-day cycles.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)'}], 'classes': [{'categories': [{'measurements': [{'value': '10.25', 'groupId': 'OG000', 'lowerLimit': '7.85', 'upperLimit': '10.87'}, {'value': '8.44', 'groupId': 'OG001', 'lowerLimit': '7.56', 'upperLimit': '9.33'}]}]}], 'analyses': [{'pValue': '0.4', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Randomization to Date of Disease Progression or Death from any cause (up to 3 years)', 'description': 'PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Phase 2 who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2228820 + Gemcitabine +Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min.(+ 15 min.) on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+).'}, {'id': 'OG001', 'title': 'Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)'}], 'classes': [{'categories': [{'measurements': [{'value': '46.6', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Disease Progression (up to 3 years)', 'description': 'Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug in Phase 2.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2228820 + Gemcitabine +Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+).'}, {'id': 'OG001', 'title': 'Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+)'}], 'classes': [{'categories': [{'measurements': [{'value': '29.17', 'groupId': 'OG000', 'lowerLimit': '23.26', 'upperLimit': '52.40'}, {'value': '25.10', 'groupId': 'OG001', 'lowerLimit': '21.95', 'upperLimit': '33.68'}]}]}], 'analyses': [{'pValue': '0.4686', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Date of Death from any cause (up to 5 years)', 'description': 'Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Phase 2 who received at least one dose of drug.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '200 mg LY2228820', 'description': 'Phase 1b (Cohort 1) and Phase 2 (Arm A): LY2228820 200 mg administered orally every 12 hours on Days 1-10, Cycles 1-6 of a 21 day cycle.\n\n.'}, {'id': 'OG001', 'title': '300 mg LY2228820', 'description': 'Phase 1b (Cohort 2) and Phase 2 (Arm A) in the maintenance portion with LY2228820 300 mg administered orally every 12 hours on Days 1-14 Cycle 7+ of a 28-day cycle.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3470', 'spread': '91', 'groupId': 'OG000'}, {'value': '3560', 'spread': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3170', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 1 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4270', 'spread': '62', 'groupId': 'OG000'}, {'value': '9350', 'spread': 'NA', 'comment': 'Due to n of 1 individual value provided.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3270', 'spread': '38', 'groupId': 'OG000'}, {'value': '3490', 'spread': 'NA', 'comment': 'Due to n of 1 individual value provided.', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7230', 'spread': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD', 'description': 'PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.', 'unitOfMeasure': 'nanograms * hr per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Phase 1b and Phase 2 who received at least one dose of study drug and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LY2228820 + Gemcitabine +Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day.\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)'}, {'id': 'OG001', 'title': 'Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '21.14', 'groupId': 'OG000'}, {'value': '-8.9', 'spread': '19.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Study Completion (up to 3 years)', 'description': 'The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = "not at all" and 4 = "very much." Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in Phase 2 who received at least one dose of study drug and had at least one post baseline assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b: Cohort 1: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).\n\nGemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin area under the concentration curve (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nCohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).'}, {'id': 'FG001', 'title': 'Phase 1b: Cohort 2: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nCohort 2: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).'}, {'id': 'FG002', 'title': 'Phase 2: Arm A: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Arm A: LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nArm A: LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)'}, {'id': 'FG003', 'title': 'Phase 2: Arm B: Placebo + Gemcitabine + Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle.\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10 of a 21-day cycle.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3 of a 21-day cycle.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '48'}, {'groupId': 'FG003', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrew Consent to Study Participation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants in Phase 1b are considered to have completed the study if they experience a dose-limiting toxicity or completed the Pharmacokinetic (PK) sampling set. Participants in Phase 2 are considered to have completed if they die due to any cause or who are alive and on study at conclusion, but are off treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b: Cohort 1: LY2228820 +Gemcitabine+Carboplatin', 'description': 'Cohort 1:LY2228820 200 milligrams (mg) administered orally every 12 hours (hr) on Days 1-10 of a 21-day cycle (Cycles 1-6).\n\nGemcitabine 1000 mg per square meter (m2) administered intravenously (IV) over 30 minutes (min) on Days 3 and 10.\n\nCarboplatin area under the concentration curve administered intravenously (IV) over 30 minutes (AUC) 4 (maximum dose 600mg) IV over 30 min. on Day 3.\n\nCohort 1: LY2228820 300 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).'}, {'id': 'BG001', 'title': 'Phase 1b: Cohort 2: LY2228820 +Gemcitabine+Carboplatin', 'description': 'Cohort 2: LY2228820 300 mg administered orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).\n\nGemcitabine 1000 mg/m2 administered IV over 30 min on Days 3 and 10.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.\n\nCohort 2:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28-day cycle (Cycles 7+).'}, {'id': 'BG002', 'title': 'Arm A: LY2228820 + Gemcitabine + Carboplatin', 'description': 'Arm A:LY2228820 200 mg orally every 12 hr. on Days 1-10 of a 21-day cycle (Cycles 1-6).\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.\n\nArm A:LY2228820 300 mg orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).'}, {'id': 'BG003', 'title': 'Arm B Placebo + Gemcitabine +Carboplatin', 'description': 'Arm B: Placebo orally every 12 hrs. on Days 1-10 of a 21-day cycle (Cycles 1-6).\n\nGemcitabine 1000 mg/m2 IV over 30 min. on Days 3 and 10.\n\nCarboplatin AUC 4 (maximum dose 600mg) IV over 30 min. on Day 3.\n\nArm B: Placebo orally every 12 hr. on Days 1-14 of a 28 day cycle (Cycles 7+).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '62.7', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '62.2', 'spread': '9.2', 'groupId': 'BG003'}, {'value': '61.6', 'spread': '9.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '113', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '118', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Maintenance Therapy as a Part of or After a First Line Platinum Regimen', 'classes': [{'title': 'Received Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}, {'title': 'Did Not Receive Maintenance Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'Data Missing or Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Maintenance therapy as part of or after first line platinum regimen data was used as a cofactor in the analysis of Progression Free Survival (PFS). Zero participants analyzed for Phase 1 portion of the study.Data was collected only from participants treated in the Phase 2 portion of the study.'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-16', 'size': 1095904, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-05T10:09', 'hasProtocol': True}, {'date': '2017-09-21', 'size': 2769662, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-03-05T10:10', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'dispFirstSubmitDate': '2018-05-04', 'completionDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-28', 'studyFirstSubmitDate': '2012-08-08', 'dispFirstSubmitQcDate': '2018-05-04', 'resultsFirstSubmitDate': '2019-05-08', 'studyFirstSubmitQcDate': '2012-08-09', 'dispFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-08', 'studyFirstPostDateStruct': {'date': '2012-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Recommended Phase 2 Dose of LY2228820 in Combination With Gemcitabine and Carboplatin (Maximum Tolerated Dose [MTD])', 'timeFrame': 'Cycle 1 (21 Days)', 'description': 'Recommended Phase 2 dose of LY2228820 that could be safely administered in combination with gemcitabine and carboplatin based on defined dose limiting toxicities (DLT) assessment and MTD definition. The MTD is defined as the highest dose level at which no more than 33% of patients experience a DLT during Cycle 1 that does not exceed the single-agent MTD for LY2228820 (300 mg Q12H).'}, {'measure': 'Phase 2: Progression-free Survival (PFS) in Participants Treated With LY2228820 Plus Gemcitabine and Carboplatin Versus Placebo Plus Gemcitabine and Carboplatin', 'timeFrame': 'Randomization to Date of Disease Progression or Death from any cause (up to 3 years)', 'description': 'PFS was defined as time from date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred first. Progressive disease (PD) is defined as at least a 20% increase in the sum of the largest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Phase 2: Percentage of Participants Who Achieve Complete Response or Partial Response (Overall Response Rate)', 'timeFrame': 'Baseline to Disease Progression (up to 3 years)', 'description': 'Overall Response Rate was estimated as the percentage of participants with best response of Complete Response (CR) or Partial Response (PR), based on RECIST version 1.1 divided by the total number of randomized participants. CR is defined as disappearance of all target lesions. PR is defined as at least 30% disease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD.'}, {'measure': 'Phase 2: Overall Survival', 'timeFrame': 'Baseline to Date of Death from any cause (up to 5 years)', 'description': 'Data presented are the median overall survival in months for participants in the Phase 2 treatment arms.'}, {'measure': 'Phase 1b and 2: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 8 Hours (AUC 0-8) of LY2228820', 'timeFrame': 'Phase1b:Cycle(C)1 Day(D)1:Predose(PRD),0.5,1,2,4,6,8 hours(hr)postdose(PD); C1D10:PRD,0.5,1,2,8hrPD; C2D10:PRD,0.5,1,2,4,6,8,12hrPD; C7D3:PRD,0.5,1,2,4,6hrPD; Phase 2: C1D3:PRD,0.5,1,2,4,6,8hrPD; C1D10:PRD,0.5,1,2,4,6,8hrPD; C7D3:PRD,0.5,1,2,4,6,8hrPD', 'description': 'PK parameters after administration of LY2228820 for both Phase 1b and Phase 2.'}, {'measure': 'Phase 2: Change From Baseline in Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) Total Score', 'timeFrame': 'Baseline, Study Completion (up to 3 years)', 'description': 'The Functional Assessment of Cancer Therapy-Ovarian Cancer (FACT-O) instrument measures health related quality of life (HRQoL) in participants with ovarian cancer. The instrument is organized into sections of physical, social/family, emotional, functional well-being and ovarian subscales with a 5-point rating scale in which 0 = "not at all" and 4 = "very much." Data presented here are change from baseline at follow-up in the FACT-O Total Score. The total score is the sum of Physical Well Being (PWB) + Social Well-being (SWB) + Emotional Well Being (EWB) + Family Well-being (FWB) + Ovarian Cancer Subscale (OCS). The FACT-O Total score range 0 - 152 with higher scores indicating better quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epithelial Ovarian Cancer', 'Fallopian Tube Cancer', 'Primary Peritoneal Cancer']}, 'referencesModule': {'references': [{'pmid': '31791552', 'type': 'DERIVED', 'citation': 'Vergote I, Heitz F, Buderath P, Powell M, Sehouli J, Lee CM, Hamilton A, Fiorica J, Moore KN, Teneriello M, Golden L, Zhang W, Pitou C, Bell R, Campbell R, Farrington DL, Bell-McGuinn K, Wenham RM. A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer. Gynecol Oncol. 2020 Jan;156(1):23-31. doi: 10.1016/j.ygyno.2019.11.006. Epub 2019 Nov 29.'}]}, 'descriptionModule': {'briefSummary': 'A study for women with ovarian cancer that has returned at least 6 months after platinum-based chemotherapy.', 'detailedDescription': 'Phase 1b is unblinded and will have a small number of participants that will take LY2228820 plus gemcitabine and carboplatin to test the safety of the combination and determine a recommended dose for the Phase 2 portion.\n\nPhase 2 will be blinded and all study participants will receive carboplatin and gemcitabine. Participants of one group will receive LY2228820, and the other group will receive placebo.\n\nIf the participant achieves at least stable disease, there is a maintenance phase following the first 6 cycles. The participant will take either LY2228820 or placebo. The participant will continue therapy until disease progression or other discontinuation criteria are fulfilled.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer\n* Have been treated one time with a platinum-based chemotherapy and your disease has come back at least six months after you completed treatment\n* Are able to swallow tablets\n* Have given written informed consent prior to any study procedures\n* Have adequate blood counts, hepatic and renal function\n* Have performance status equal to or less than 2 on Eastern Cooperative Oncology Group (ECOG) scale\n* Have negative pregnancy test, and if participant is of child bearing potential must use birth control while on study and for three months after stopping study drug\n\nExclusion Criteria:\n\n* Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer\n* Are currently enrolled or discontinued less than 14 days from another clinical trial\n* Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)\n* Have taken certain medications or had grapefruit juice within 7 days of initial dose of study drug, as levels of the study drug may be affected.\n* Must not be pregnant or breastfeeding.\n* Have malignancy or metastasis of the central nervous system\n* Have borderline malignancy"}, 'identificationModule': {'nctId': 'NCT01663857', 'briefTitle': 'A Study LY2228820 for Recurrent Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Phase 1b/2 Study of LY2228820, a p38 MAPK Inhibitor, Plus Gemcitabine and Carboplatin Versus Gemcitabine and Carboplatin for Women With Platinum-Sensitive Ovarian Cancer', 'orgStudyIdInfo': {'id': '12517'}, 'secondaryIdInfos': [{'id': 'I1D-MC-JIAE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)', 'description': 'Cohort 1: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 milligrams per square meter (mg/m\\^2) administered intravenously (IV) over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3..\n\nCohort 1: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.', 'interventionNames': ['Drug: LY2228820', 'Drug: Carboplatin', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1b (Cohort 2) LY2228820 300 mg', 'description': 'Cohort 2: Cycles 1-6 (21 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.\n\nCohort 2: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.', 'interventionNames': ['Drug: LY2228820', 'Drug: Carboplatin', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 (Arm A) LY2228820 200 mg', 'description': 'Arm A: Cycles 1-6 (21 day cycles)- LY2228820 200 mg administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.\n\nArm A: Cycles 7+ (28 day cycles)- LY2228820 300 mg administered orally every 12 hours on days 1-14.', 'interventionNames': ['Drug: LY2228820', 'Drug: Carboplatin', 'Drug: Gemcitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2 (Arm B) Placebo', 'description': 'Arm B: Cycles 1-6 (21 day cycles)- Placebo administered orally every 12 hours on days 1-10. Gemcitabine 1000 mg/m\\^2 administered IV over 30 minutes on days 3 and 10. Carboplatin dose Area Under Curve (AUC) 4 (maximum dose 600 mg) administered IV over 30 minutes on day 3.\n\nArm B: Cycle 7+ (28 day cycles)- Placebo administered orally on days 1-14 to maintain blind.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Placebo', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'LY2228820', 'type': 'DRUG', 'description': 'Administered Orally', 'armGroupLabels': ['Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)', 'Phase 1b (Cohort 2) LY2228820 300 mg', 'Phase 2 (Arm A) LY2228820 200 mg']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)', 'Phase 1b (Cohort 2) LY2228820 300 mg', 'Phase 2 (Arm A) LY2228820 200 mg', 'Phase 2 (Arm B) Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered Orally', 'armGroupLabels': ['Phase 2 (Arm B) Placebo']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['Gemzar', 'LY188011'], 'description': 'Administered IV', 'armGroupLabels': ['Phase 1b (Cohort 1) LY2228820 200 milligrams (mg)', 'Phase 1b (Cohort 2) LY2228820 300 mg', 'Phase 2 (Arm A) LY2228820 200 mg', 'Phase 2 (Arm B) Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'St Josephs Hospital and Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85710', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, P.C.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Memorial Hospital', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H Lee Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '21237', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Franklin Square Hospital Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'SMO Sarah Cannon Research Inst.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76022', 'city': 'Bedford', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.84402, 'lon': -97.14307}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology-Baylor Charles A. Sammons Cancer Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Care Centers of South Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - The Woodlands', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists PC', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '5000', 'city': 'Adelaide', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '4120', 'city': 'Greenslopes', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -27.50815, 'lon': 153.04951}}, {'zip': '6009', 'city': 'Nedlands', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '3053', 'city': 'Parkville', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45136', 'city': 'Essen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '17489', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9am-5pm Eastern time *UTC/GMT-5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}