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Ignite Creation Date: 2025-12-24 @ 4:33 PM

Ignite Modification Date: 2026-02-28 @ 8:50 PM

Study NCT ID: NCT02502266

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-12-01

First Post: 2015-07-17

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube 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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500926', 'term': 'cediranib'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C531550', 'term': 'olaparib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D013660', 'term': 'Taxes'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'purdyc@nrgoncology.org', 'phone': '(716) 845-1300', 'title': 'Christopher Purdy on behalf of Austin Miller, PhD', 'phoneExt': '2296', 'organization': 'NRG Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years', 'description': 'Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term.\n\nAll-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV", 'otherNumAtRisk': 156, 'deathsNumAtRisk': 173, 'otherNumAffected': 151, 'seriousNumAtRisk': 156, 'deathsNumAffected': 137, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 167, 'otherNumAffected': 162, 'seriousNumAtRisk': 163, 'deathsNumAffected': 145, 'seriousNumAffected': 21}, {'id': 'EG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 170, 'otherNumAffected': 162, 'seriousNumAtRisk': 162, 'deathsNumAffected': 143, 'seriousNumAffected': 19}, {'id': 'EG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 52, 'otherNumAffected': 46, 'seriousNumAtRisk': 49, 'deathsNumAffected': 45, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': 'Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 5, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Cardiac disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Conduction disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Left ventricular systolic dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pulmonary valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tricuspid valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear and labyrinth disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 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{'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Vaginal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}, {'term': 'Visceral arterial ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (5.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) (Phase II Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '4.2'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '8.2'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '4.8'}, {'value': '2.3', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '2.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.649', 'ciLowerLimit': '0.424', 'ciUpperLimit': '0.995', 'estimateComment': 'The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \\< 0.83) were recommended for further evaluation in the phase III trial.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.832', 'ciLowerLimit': '0.539', 'ciUpperLimit': '1.284', 'estimateComment': 'The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \\< 0.83) were recommended for further evaluation in the phase III trial.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.149', 'ciLowerLimit': '0.745', 'ciUpperLimit': '1.773', 'estimateComment': 'The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Experimental regimens with at least a 17% reduction in the estimated PFS event rate (compared to standard chemotherapy) (HR estimate \\< 0.83) were recommended for further evaluation in the phase III trial.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.', 'description': 'Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments.\n\nDisease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized at Phase II.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) (Phase III Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm V: (Arm 1 Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'OG004', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'OG005', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '4.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.2'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '3.2', 'upperLimit': '4.3'}, {'value': '4.2', 'comment': 'The sample size is not sufficient for the estimation of the upper bound of the CI.', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': 'NA'}, {'value': '5.3', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '12.6'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '2.3', 'upperLimit': '4.8'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '0.796', 'ciLowerLimit': '0.597', 'ciUpperLimit': '1.060', 'pValueComment': 'The log rank test was stratified by the factors provided at randomization', 'estimateComment': 'The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '1.0', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '0.972', 'ciLowerLimit': '0.726', 'ciUpperLimit': '1.00', 'estimateComment': 'The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The log rank test was stratified by the factors provided at randomization.'}], 'paramType': 'MEDIAN', 'timeFrame': 'The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.', 'description': 'Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments.\n\nDisease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects in Arms I - VII (excluding Arm IV).\n\nArm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.\n\nThe primary endpoint analysis also did not include 20 Japanese patients who were enrolled after the primary Phase III endpoint was reached.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) (Phase III Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}, {'value': '170', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'OG004', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'OG005', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '15.8'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '15.3'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '12.3'}, {'value': '14.9', 'comment': 'The sample size is not sufficient for the estimation of the upper bound of the CI.', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': 'NA'}, {'value': '18.0', 'comment': 'The sample size is not sufficient for the estimation of the upper bound of the CI.', 'groupId': 'OG004', 'lowerLimit': '2.8', 'upperLimit': 'NA'}, {'value': '5.8', 'groupId': 'OG005', 'lowerLimit': '3.6', 'upperLimit': '17.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '1.027', 'ciLowerLimit': '0.771', 'ciUpperLimit': '1.368', 'pValueComment': 'No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.', 'estimateComment': 'The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98', 'paramValue': '1.060', 'ciLowerLimit': '0.795', 'ciUpperLimit': '1.413', 'pValueComment': 'No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.', 'estimateComment': 'The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \\<1.0.', 'groupDescription': 'Arm IV was suspended for futility at the end of Phase 2 analysis, so was not analyzed at the final analysis.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'No p-values are provided because testing each of these null hypotheses was conditioned on first rejecting hypothesis concerning PFS.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from study enrollment to death due to any cause, assessed up to 5 years', 'description': 'Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects in Arms I - VII (excluding Arm IV).\n\nArm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.\n\nTwenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis for overall survival.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (Complete Response and Partial Response) (Phase II Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.\n\nA Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients randomized at phase II and with measurable disease.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (Complete Response and Partial Response for Phase III Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'OG004', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'OG005', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.\n\nA Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with measurable disease in Arms I - VII (excluding Arm IV).\n\nArm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.\n\nTwenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of overall response rates.'}, {'type': 'SECONDARY', 'title': 'Incidence of Grade 3 (or Higher) Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '162', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'OG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'OG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT'}, {'id': 'OG004', 'title': 'Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'OG005', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'OG006', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 5 years', 'description': 'Adverse events will be categorized by CTCAE V4.0. This outcome will report the count of participants who experienced a grade 3 (or higher) adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized and treated patients in Arms I - VII.\n\nArm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm.\n\nTwenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of adverse events.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Patient-reported Scores of Disease-related Symptoms', 'timeFrame': 'Up to 5 years', 'description': 'Measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI-18).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Gene Mutations Assessed BROCA-HR', 'timeFrame': 'Up to 5 years', 'description': 'A single proportional hazards model will be used to estimate the treatment hazard ratios (and variances) for each of the experimental treatments selected for phase III evaluation relative to the reference treatment (chemotherapy) group. The model will include adjustments for prior platinum-free interval, prior bevacizumab treatment, age at study enrollment, randomly assigned study treatment and BROCA-HR status. The estimated hazard ratio(s) for BROCA-HR and the corresponding confidence intervals will be depicted with a forest plot, and assessed for qualitative interaction(s).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Circulating Endothelial Cell Levels', 'timeFrame': 'Baseline up to 5 years', 'description': 'A proportional hazards model will be used to assess a linear association between the change in circulating endothelial cell values and the log relative hazard of death within each treatment group. Sensitivity analyses will include known prognostic factors in the model. A plot of the martingale residuals or estimated relative hazards by change in circulating endothelial cell quintiles will be used to qualitatively assess the assumption of a linear relationship between the change in circulating endothelial cell values and the log relative hazard.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Biomarkers in Plasma Angiome', 'timeFrame': 'Up to 5 years', 'description': "A proportional hazards model will be used to assess whether the pretreatment values of any of these analytes have a prognostic association with overall survival. The model will include clinical covariates: age, performance status, and the randomly assigned study treatment. Proportional hazards models will be used to assess the relationship between patients' analyte values and log hazard. A proportional hazards model will be used to assess the potential predictive associations between analytes, treatment and survival.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'FG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'FG004', 'title': 'Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'FG005', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'FG006', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '167'}, {'groupId': 'FG002', 'numSubjects': '170'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '139'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '31'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Still on Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Arm 4 Discontinued', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '52'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study opened on 05 Feb 2016. Phase 2 accrual completed on 16 Jun 2017 with 213 patients randomly assigned to 4 treatment arms. Enrollment to Arm IV (olaparib) was suspended after DMC review and 52 patients on Arm IV during phase 2 not included in phase 3 analysis. Phase 3 accrual started on 17 Dec 2018 with 349 patients including 4 Japanese patients enrolled to Phase 3 three arms by 02 Oct 2020. After that, 20 Japanese patients were enrolled but not included in the phase 3 analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '582', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Reference Regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nPaclitaxel: Given IV\n\nPegylated Liposomal Doxorubicin Hydrochloride: Given IV\n\nQuestionnaire Administration: Ancillary studies\n\nTopotecan: Given IV\n\nTopotecan Hydrochloride: Given IV"}, {'id': 'BG001', 'title': 'Arm II (Cediranib Maleate, Olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG002', 'title': 'Arm III (Cediranib Maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nCediranib: Given PO\n\nCediranib Maleate: Given PO\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG003', 'title': 'Arm IV (Olaparib) (Phase II Only)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nComputed Tomography: Undergo CT\n\nMagnetic Resonance Imaging: Undergo MRI\n\nOlaparib: Given PO\n\nQuestionnaire Administration: Ancillary studies'}, {'id': 'BG004', 'title': 'Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff."}, {'id': 'BG005', 'title': 'Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.'}, {'id': 'BG006', 'title': 'Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '44', 'groupId': 'BG007'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '129', 'groupId': 'BG007'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '223', 'groupId': 'BG007'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '158', 'groupId': 'BG007'}]}]}, {'title': '>= 80 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '173', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '582', 'groupId': 'BG007'}]}, {'title': 'Male', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '19', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '549', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '62', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '464', 'groupId': 'BG007'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '16', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized Subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-27', 'size': 4753423, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-11-05T10:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 582}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2015-07-17', 'resultsFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-14', 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient-reported Scores of Disease-related Symptoms', 'timeFrame': 'Up to 5 years', 'description': 'Measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI-18).'}, {'measure': 'Gene Mutations Assessed BROCA-HR', 'timeFrame': 'Up to 5 years', 'description': 'A single proportional hazards model will be used to estimate the treatment hazard ratios (and variances) for each of the experimental treatments selected for phase III evaluation relative to the reference treatment (chemotherapy) group. The model will include adjustments for prior platinum-free interval, prior bevacizumab treatment, age at study enrollment, randomly assigned study treatment and BROCA-HR status. The estimated hazard ratio(s) for BROCA-HR and the corresponding confidence intervals will be depicted with a forest plot, and assessed for qualitative interaction(s).'}, {'measure': 'Change in Circulating Endothelial Cell Levels', 'timeFrame': 'Baseline up to 5 years', 'description': 'A proportional hazards model will be used to assess a linear association between the change in circulating endothelial cell values and the log relative hazard of death within each treatment group. Sensitivity analyses will include known prognostic factors in the model. A plot of the martingale residuals or estimated relative hazards by change in circulating endothelial cell quintiles will be used to qualitatively assess the assumption of a linear relationship between the change in circulating endothelial cell values and the log relative hazard.'}, {'measure': 'Biomarkers in Plasma Angiome', 'timeFrame': 'Up to 5 years', 'description': "A proportional hazards model will be used to assess whether the pretreatment values of any of these analytes have a prognostic association with overall survival. The model will include clinical covariates: age, performance status, and the randomly assigned study treatment. Proportional hazards models will be used to assess the relationship between patients' analyte values and log hazard. A proportional hazards model will be used to assess the potential predictive associations between analytes, treatment and survival."}], 'primaryOutcomes': [{'measure': 'Progression-free Survival (PFS) (Phase II Only)', 'timeFrame': 'The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.', 'description': 'Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments.\n\nDisease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).'}, {'measure': 'Progression-free Survival (PFS) (Phase III Only)', 'timeFrame': 'The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.', 'description': 'Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments.\n\nDisease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).'}, {'measure': 'Overall Survival (OS) (Phase III Only)', 'timeFrame': 'Time from study enrollment to death due to any cause, assessed up to 5 years', 'description': 'Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (Complete Response and Partial Response) (Phase II Only)', 'timeFrame': 'Up to 5 years', 'description': 'The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.\n\nA Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.'}, {'measure': 'Objective Response Rate (Complete Response and Partial Response for Phase III Only)', 'timeFrame': 'Up to 5 years', 'description': 'The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.\n\nA Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.'}, {'measure': 'Incidence of Grade 3 (or Higher) Adverse Events', 'timeFrame': 'Up to 5 years', 'description': 'Adverse events will be categorized by CTCAE V4.0. This outcome will report the count of participants who experienced a grade 3 (or higher) adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fallopian Tube Clear Cell Adenocarcinoma', 'Fallopian Tube Endometrioid Adenocarcinoma', 'Fallopian Tube Serous Adenocarcinoma', 'Fallopian Tube Transitional Cell Carcinoma', 'Fallopian Tube Undifferentiated Carcinoma', 'Ovarian Clear Cell Adenocarcinoma', 'Ovarian Endometrioid Adenocarcinoma', 'Ovarian Seromucinous Carcinoma', 'Ovarian Serous Adenocarcinoma', 'Ovarian Transitional Cell Carcinoma', 'Ovarian Undifferentiated Carcinoma', 'Primary Peritoneal Serous Adenocarcinoma', 'Recurrent Fallopian Tube Carcinoma', 'Recurrent Ovarian Carcinoma', 'Recurrent Primary Peritoneal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39361946', 'type': 'DERIVED', 'citation': 'Lee JM, Brady MF, Miller A, Moore RG, MacKay H, McNally L, Lea J, Street D, Lheureux S, McDonald ME, Duska LR, Cantuaria G, Kavecansky J, Leath CA 3rd, Powell M, Cadungog MG, Rose PG, Kim YM, Huang HQ, Provencher M, Wenzel LB, Bookman MA, Kohn EC, Secord AA. Cediranib and Olaparib Combination Compared With Cediranib or Olaparib Alone, or Chemotherapy in Platinum-Resistant or Primary Platinum-Refractory Ovarian Cancer: NRG-GY005. J Clin Oncol. 2024 Dec 20;42(36):4305-4316. doi: 10.1200/JCO.24.00683. Epub 2024 Oct 3.'}]}, 'descriptionModule': {'briefSummary': 'This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.', 'detailedDescription': "PRIMARY OBJECTIVES:\n\nI. To assess the efficacy and identify (in)active arm(s) of the combination of cediranib maleate (cediranib) and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by overall survival (OS) and PFS, as compared to physician's choice standard of care chemotherapy in women with recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)\n\nSECONDARY OBJECTIVES:\n\nI. To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events (CTCAE). (Phase II and Phase III) III. To assess the efficacy of the combination of cediranib and olaparib, and cediranib monotherapy, as measured by ORR as compared to physician's choice standard of care chemotherapy in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)\n\nOBJECTIVES WITH INTEGRATED BIOMARKERS:\n\nI. To assess correlation of homologous recombination deficiency (HRD) status, as assessed via BROCA-HR assay with response, as measured by PFS and ORR. (Phase II) II. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase II) III. To evaluate quality of life data compliance, as measured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI) for utilization and analysis in the Phase III study. (Phase II) IV. To assess correlation of HRD status, as assessed via BROCA-HR assay with response, as measured by OS, PFS and ORR. (Phase III) V. To evaluate the prognostic and predictive role of circulating endothelial cells (CEC) on comparative effectiveness of targeted therapies and reference chemotherapy. (Phase III) VI. To assess the effect on disease-related symptoms (DRS) as measured by the 9-item DRS-P subscale of the NCCN-FACT Ovarian Symptom Index-18 (NFOSI-18), of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)\n\nEXPLORATORY OBJECTIVES:\n\nI. To assess exploratory biomarkers of potential HRD, including genomic scarring, BRCA1 methylation, BRCA1 protein expression, and mutations in NHEJ, and other genes that might modify HRD. (Phase II and Phase III) II. To evaluate the prognostic and predictive role of angiogenic biomarkers, as assessed by the Duke plasma angiome. (Phase II and Phase III) III. To assess the effect on secondary measures of quality of life, as assessed by the treatment side effects (TSE) and function/well-being (F/WB) subscales of the NFOSI-18, sensory neuropathy as measured by the FACT/GOG-Ntx-4, and health utility as measured by the EQ-5D, of single agent cediranib and cediranib/olaparib combination, compared to standard chemotherapy, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)\n\nOUTLINE:\n\nPHASE II: Patients are randomized to 1 of 4 treatment arms.\n\nARM I (REFERENCE REGIMEN): Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016)\n\nARM II (CEDIRANIB MALEATE AND OLAPARIB): Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nARM III (CEDIRANIB): Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nARM IV (OLAPARIB): Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).\n\nPHASE III: Patients are randomized to 1 of 3 treatment arms.\n\nARM I (REFERENCE REGIMEN): Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)\n\nARM II (CEDIRANIB AND OLAPARIB): Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.\n\nARM III (SINGLE AGENT): Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.\n\nAfter completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer and must have a histological diagnosis of either serous or endometrioid cancer based on local histopathological findings; both endometrioid and serous histology should be high-grade for eligibility of non-mutation carriers; patients with clear cell, mixed epithelial, undifferentiated carcinoma, or transitional cell carcinoma histologies are also eligible, provided that the patient has a known deleterious germline BRCA1 or BRCA2 mutation identified through testing at a clinical laboratory\n\n * Note: Due to the long acceptance of BRCA testing through Myriad, Myriad testing will be accepted; if testing for BRCA is done by other organizations, documentation from a qualified medical professional (e.g., ovarian cancer specialty physician involved in the field, high risk genetics physician, genetics counselor) listing the mutation and confirming that the laboratory results showed a recognized germ line deleterious BRCA 1 or BRCA 2 mutation or BRCA rearrangement is required (12/05/2016); a copy of Myriad or other BRCA mutational analysis (positive or variants of unknown significance \\[VUS\\] or negative) reports will be requested but not required for study enrollment\n* Patients should have recurrent platinum-resistant or- refractory disease - defined as disease that has progressed by imaging while receiving platinum or had recurrence within 6 months of the last receipt of platinum-based chemotherapy; rising CA125 only is not considered as platinum-resistant or refractory disease (12/05/2016)\n* Phase II study: measurable disease by RECIST 1.1 criteria; if archival tumor sample is not available tumor sample from fresh biopsy is acceptable (12/05/2016)\n* Phase III study: evaluable disease - defined as RECIST 1.1 measurable disease OR non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions OR ascites and/or pleural effusion that has been pathologically demonstrated to be disease-related in the setting of a cancer antigen \\[CA\\]125 \\>= 2 x upper limit of normal \\[ULN\\])\n* No more than 3 prior treatment regimens (including primary therapy; no more than 1 prior non-platinum based therapy in the platinum-resistant/-refractory setting); hormonal therapies used as single agents (i.e. tamoxifen, aromatase inhibitors) will not count towards this line limit (12/05/2016)\n* Patients may not have had a prior anti-angiogenic agent in the recurrent setting; prior use of bevacizumab in the upfront or upfront maintenance setting is allowed\n* Patients may not have previously received a PARP-inhibitor\n* Patient must have provided study specific informed consent prior to study entry\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2\n* Absolute neutrophil count \\>= 1,500/mcL (12/05/2016)\n* Platelets \\>= 100,000/mcL (12/05/2016)\n* Hemoglobin \\>= 10 g/dL (12/05/2016)\n* Total bilirubin within =\\< 1.5 times the upper limit of normal (ULN) institutional limits (12/05/2016)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 3 x institutional ULN; if intrahepatic liver metastases are present, AST and ALT must be =\\< 5 times institutional ULN (12/05/2016)\n* Creatinine =\\< 1.5 x the institutional ULN (12/05/2016)\n* Urine protein: creatinine ratio urine protein creatinine (UPC) of =\\< 1 OR less than or equal to 2+ proteinuria on two consecutive dipsticks taken no less than 1 week apart; UPC is the preferred test; patients with 2+ proteinuria on dipstick must also have a 24-hour urine collection demonstrating protein of =\\< 500 mg over 24 hours (12/05/2016)\n* Toxicities of prior therapy (excepting alopecia) should be resolved to less than or equal to grade 1 as per CTCAE; patients with long-standing stable grade 2 neuropathy may be considered after discussion with the study chair.\n* Adequately controlled blood pressure (systolic blood pressure \\[SBP\\] =\\< 140; diastolic blood pressure \\[DBP\\] =\\< 90 mmHg) on maximum of three antihypertensive medications; patients must have a BP of =\\< 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study; it is strongly recommended that patients who are on three antihypertensive medications be followed by a cardiologist or a primary care physician for management of BP while on protocol; patients must be willing and able to check and record daily blood pressure readings; blood pressure cuffs will be provided to patients randomized to cediranib alone and the combination of olaparib and cediranib arms (12/05/2016)\n* Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits (12/05/2016)\n* Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib\n* Age \\>= 18 years\n* Cediranib has been shown to terminate fetal development in the rat, as expected for a process dependent on VEGF signaling; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 weeks after cediranib discontinuation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Olaparib adversely affects embryofetal survival and development in the rat; for this reason, women of child-bearing potential must have a negative pregnancy test prior to study entry; women of child-bearing potential must agree to use must agree to use two reliable forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the last dose of olaparib; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of starting treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients may not have had hormonal therapy within 2 weeks prior to entering the study; patients receiving raloxifene for bone health as per Food and Drug Administration (FDA) indication may remain on raloxifene absent other drug interactions (12/05/2016)\n* Any other investigational agents within the past 4 weeks\n* Prior treatment affecting the VEGF/VEGFR pathway or the angiopoietin pathway in the recurrent setting, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, pazopanib, cediranib, nintedanib, and trebananib; bevacizumab used in the upfront setting in conjunction with chemotherapy and/or as maintenance to treat newly diagnosed disease will be allowed\n* Prior use of PARP-inhibitors\n* CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib\n* Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs\n* History of intra-abdominal abscess within the past 3 months\n* History of gastrointestinal perforation; patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired or has healed, there has been no evidence of fistula for at least 6 months, and patient is deemed to be at low risk of recurrent fistula (12/05/2016)\n* Dependency on IV hydration or total parenteral nutrition (TPN)\n* Any concomitant or prior invasive malignancies with the following curatively treated exceptions:\n\n * Treated limited stage basal cell or squamous cell carcinoma of the skin\n * Carcinoma in situ of the breast or cervix\n * Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions (12/05/2016)\n * Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence\n* Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should not be included on this study, since neurologic dysfunction may confound the evaluation of neurologic and other adverse events; patients with treated brain metastases and resolution of any associated symptoms must demonstrate stable post-therapeutic imaging for at least 6 months following therapy prior to starting study drug\n* Patients with any of the following:\n\n * History of myocardial infarction within six months\n * Unstable angina\n * Resting electrocardiogram (ECG) with clinically significant abnormal findings\n * New York Heart Association functional classification of III or IV\n* If cardiac function assessment is clinically indicated or performed: left ventricular ejection fraction (LVEF) less than normal per institutional guidelines, or \\< 55%, if threshold for normal not otherwise specified by institutional guidelines\n\n * Patients with the following risk factors should have a baseline cardiac function assessment:\n\n * Prior treatment with anthracyclines\n * Prior treatment with trastuzumab\n * Prior central thoracic radiation therapy (RT), including RT to the heart\n * History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)\n * Prior history of impaired cardiac function\n* History of stroke or transient ischemic attack within six months\n* Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)\n* Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted\n* Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated\n\n * No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)\n* Patients may not use any complementary or alternative medicines including natural herbal products or folk remedies as they may interfere with the effectiveness of the study treatments\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (other than atrial fibrillation with controlled ventricular rate), or psychiatric illness/social situations that would limit compliance with study requirements (12/05/2016)\n* Known human immunodeficiency virus (HIV)-positive individuals are ineligible because of the potential for pharmacokinetic interactions with cediranib or olaparib; in addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy\n* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible\n\n * Strong inhibitors and inducers of UGT/PgP should be used with caution (12/05/2016)\n* Pregnant women are excluded from this study because cediranib and olaparib are agents with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with cediranib and olaparib, breastfeeding should be discontinued if the mother is treated with cediranib or olaparib; these potential risks may also apply to other agents used in this study'}, 'identificationModule': {'nctId': 'NCT02502266', 'briefTitle': 'Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women With Recurrent Platinum-Resistant or -Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)', 'orgStudyIdInfo': {'id': 'NCI-2015-00651'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00651', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'NRG-GY005'}, {'id': 's16-01681'}, {'id': 'NRG-GY005', 'type': 'OTHER', 'domain': 'NRG Oncology'}, {'id': 'NRG-GY005', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180868', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180868', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Phase II Arm I (reference regimen)', 'description': "Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)", 'interventionNames': ['Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Drug: Paclitaxel', 'Drug: Pegylated Liposomal Doxorubicin Hydrochloride', 'Other: Questionnaire Administration', 'Drug: Topotecan', 'Drug: Topotecan Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Arm II (cediranib maleate, olaparib)', 'description': 'Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.', 'interventionNames': ['Drug: Cediranib', 'Drug: Cediranib Maleate', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Drug: Olaparib', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Arm III (cediranib maleate)', 'description': 'Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.', 'interventionNames': ['Drug: Cediranib', 'Drug: Cediranib Maleate', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Arm IV (olaparib)', 'description': 'Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).', 'interventionNames': ['Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Drug: Olaparib', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase III Arm I (reference regimen)', 'description': "Patients undergo physician's choice standard of care chemotherapy as in Phase II Arm I. No modification of the assigned regimens, such as additional drugs (gemcitabine or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)", 'interventionNames': ['Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Drug: Paclitaxel', 'Drug: Pegylated Liposomal Doxorubicin Hydrochloride', 'Other: Questionnaire Administration', 'Drug: Topotecan', 'Drug: Topotecan Hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'Phase III Arm II (cediranib maleate, olaparib)', 'description': 'Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.', 'interventionNames': ['Drug: Cediranib', 'Drug: Cediranib Maleate', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Drug: Olaparib', 'Other: Questionnaire Administration']}, {'type': 'EXPERIMENTAL', 'label': 'Phase III Arm III (single-agent cediranib maleate)', 'description': 'Patients receive cediranib maleate PO as determined by the Phase II study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.', 'interventionNames': ['Drug: Cediranib', 'Drug: Cediranib Maleate', 'Procedure: Computed Tomography', 'Procedure: Magnetic Resonance Imaging', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Cediranib', 'type': 'DRUG', 'otherNames': ['AZ-D2171', 'AZD 2171', 'AZD2171'], 'description': 'Given PO', 'armGroupLabels': ['Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm III (cediranib maleate)', 'Phase III Arm II (cediranib maleate, olaparib)', 'Phase III Arm III (single-agent cediranib maleate)']}, {'name': 'Cediranib Maleate', 'type': 'DRUG', 'otherNames': ['AZD2171', 'AZD2171 Maleate', 'Recentin'], 'description': 'Given PO', 'armGroupLabels': ['Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm III (cediranib maleate)', 'Phase III Arm II (cediranib maleate, olaparib)', 'Phase III Arm III (single-agent cediranib maleate)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm III (cediranib maleate)', 'Phase II Arm IV (olaparib)', 'Phase III Arm I (reference regimen)', 'Phase III Arm II (cediranib maleate, olaparib)', 'Phase III Arm III (single-agent cediranib maleate)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm III (cediranib maleate)', 'Phase II Arm IV (olaparib)', 'Phase III Arm I (reference regimen)', 'Phase III Arm II (cediranib maleate, olaparib)', 'Phase III Arm III (single-agent cediranib maleate)']}, {'name': 'Olaparib', 'type': 'DRUG', 'otherNames': ['AZD 2281', 'AZD-2281', 'AZD2281', 'KU 0059436', 'KU-0059436', 'KU0059436', 'Lynparza', 'Olanib', 'Olaparix', 'PARP Inhibitor AZD2281'], 'description': 'Given PO', 'armGroupLabels': ['Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm IV (olaparib)', 'Phase III Arm II (cediranib maleate, olaparib)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'otherNames': ['Anzatax', 'Asotax', 'Bristaxol', 'Praxel', 'Taxol', 'Taxol Konzentrat'], 'description': 'Given IV', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase III Arm I (reference regimen)']}, {'name': 'Pegylated Liposomal Doxorubicin Hydrochloride', 'type': 'DRUG', 'otherNames': ['ATI-0918', 'Caelyx', 'Dox-SL', 'Doxil', 'Doxilen', 'Doxorubicin HCl Liposomal', 'Doxorubicin HCl Liposome', 'Doxorubicin Hydrochloride Liposome', 'Duomeisu', 'Evacet', 'LipoDox', 'Lipodox 50', 'Liposomal Adriamycin', 'Liposomal Doxorubicin Hydrochloride', 'Liposomal-Encapsulated Doxorubicin', 'Pegylated Doxorubicin HCl Liposome', 'Pegylated Liposomal Doxorubicin', 'S-Liposomal Doxorubicin', 'Stealth Liposomal Doxorubicin', 'TLC D-99'], 'description': 'Given IV', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase III Arm I (reference regimen)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase II Arm II (cediranib maleate, olaparib)', 'Phase II Arm III (cediranib maleate)', 'Phase II Arm IV (olaparib)', 'Phase III Arm I (reference regimen)', 'Phase III Arm II (cediranib maleate, olaparib)', 'Phase III Arm III (single-agent cediranib maleate)']}, {'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Hycamptamine', 'Topotecan Lactone'], 'description': 'Given IV', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase III Arm I (reference regimen)']}, {'name': 'Topotecan Hydrochloride', 'type': 'DRUG', 'otherNames': ['Evotopin', 'Hycamptamine', 'Hycamtin', 'Nogitecan Hydrochloride', 'Potactasol', 'SKF S 104864 A', 'SKF S-104864-A', 'SKF S104864A', 'Topotec', 'Topotecan HCl', 'topotecan hydrochloride (oral)'], 'description': 'Given IV', 'armGroupLabels': ['Phase II Arm I (reference regimen)', 'Phase III Arm I (reference regimen)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '99508', 'city': 'Anchorage', 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