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Active, not recruitingNCT02502266Updated Oct 1, 2026Results posted

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

A Phase 2/3 interventional study of Cediranib and Cediranib Maleate in Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma and Fallopian Tube Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI). Active, not recruiting at 398 sites in 5 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by National Cancer Institute (NCI) · Phase 2/3, Interventional, and Treatment

Updated Oct 1, 20261 site added1 site removedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
582
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

Read the detailed description

PRIMARY OBJECTIVES:

I. 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)

SECONDARY OBJECTIVES:

I. 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)

OBJECTIVES WITH INTEGRATED BIOMARKERS:

I. 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)

EXPLORATORY OBJECTIVES:

I. 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)

OUTLINE:

PHASE II: Patients are randomized to 1 of 4 treatment arms.

ARM 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)

ARM 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.

ARM 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.

ARM 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).

PHASE III: Patients are randomized to 1 of 3 treatment arms.

ARM 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)

ARM 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.

ARM 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.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 3 years.

02

Conditions studied

  • 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
03

In context

Fallopian Tube Neoplasms

720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.

This study's enrollment of 582 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.

Browse Fallopian Tube Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

    • 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
  • 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)
  • 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)
  • 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])
  • 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)
  • 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
  • Patients may not have previously received a PARP-inhibitor
  • Patient must have provided study specific informed consent prior to study entry
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2
  • Absolute neutrophil count >= 1,500/mcL (12/05/2016)
  • Platelets >= 100,000/mcL (12/05/2016)
  • Hemoglobin >= 10 g/dL (12/05/2016)
  • Total bilirubin within =\< 1.5 times the upper limit of normal (ULN) institutional limits (12/05/2016)
  • 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)
  • Creatinine =\< 1.5 x the institutional ULN (12/05/2016)
  • 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)
  • 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.
  • 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)
  • Adequately controlled thyroid function, with no symptoms of thyroid dysfunction and thyroid-stimulating hormone (TSH) within normal limits (12/05/2016)
  • Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of cediranib or olaparib
  • Age >= 18 years
  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Any other investigational agents within the past 4 weeks
  • 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
  • Prior use of PARP-inhibitors
  • CA-125 only disease without Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable or otherwise evaluable disease
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib
  • Current signs and/or symptoms of bowel obstruction or signs and/or symptoms of bowel obstruction within 3 months prior to starting study drugs
  • History of intra-abdominal abscess within the past 3 months
  • 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)
  • Dependency on IV hydration or total parenteral nutrition (TPN)

  • Any concomitant or prior invasive malignancies with the following curatively treated exceptions:

    • Treated limited stage basal cell or squamous cell carcinoma of the skin
    • Carcinoma in situ of the breast or cervix
    • 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)
    • 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
  • 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

  • Patients with any of the following:

    • History of myocardial infarction within six months
    • Unstable angina
    • Resting electrocardiogram (ECG) with clinically significant abnormal findings
    • New York Heart Association functional classification of III or IV

  • 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

    • Patients with the following risk factors should have a baseline cardiac function assessment:

      • Prior treatment with anthracyclines
      • Prior treatment with trastuzumab
      • Prior central thoracic radiation therapy (RT), including RT to the heart
      • History of myocardial infarction within 6 to 12 months (Patients with history of myocardial infarction within 6 months are excluded from the study)
      • Prior history of impaired cardiac function
  • History of stroke or transient ischemic attack within six months
  • Clinical significant peripheral vascular disease or vascular disease (aortic aneurysm or aortic dissection)
  • Evidence of coagulopathy or bleeding diathesis; therapeutic anticoagulation for prior thromboembolic events is permitted

  • Evidence suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated

    • No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUBCT)
  • 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
  • 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)
  • 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

  • Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible

    • Strong inhibitors and inducers of UGT/PgP should be used with caution (12/05/2016)
  • 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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
582 participants (actual)

Study arms

  • Active comparator
    Phase II Arm I (reference regimen)

    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)

    Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Paclitaxel · Drug: Pegylated Liposomal Doxorubicin Hydrochloride · Other: Questionnaire Administration · Drug: Topotecan · Drug: Topotecan Hydrochloride

  • Experimental
    Phase II Arm II (cediranib maleate, olaparib)

    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.

    Drug: Cediranib · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Olaparib · Other: Questionnaire Administration

  • Experimental
    Phase II Arm III (cediranib maleate)

    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.

    Drug: Cediranib · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration

  • Experimental
    Phase II Arm 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).

    Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Olaparib · Other: Questionnaire Administration

  • Active comparator
    Phase III Arm 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)

    Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Paclitaxel · Drug: Pegylated Liposomal Doxorubicin Hydrochloride · Other: Questionnaire Administration · Drug: Topotecan · Drug: Topotecan Hydrochloride

  • Experimental
    Phase III Arm II (cediranib maleate, olaparib)

    Patients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.

    Drug: Cediranib · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Drug: Olaparib · Other: Questionnaire Administration

  • Experimental
    Phase III Arm III (single-agent cediranib maleate)

    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.

    Drug: Cediranib · Drug: Cediranib Maleate · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Other: Questionnaire Administration

Interventions

  • DrugCediranib

    Given PO

    Also known as: AZ-D2171, AZD 2171, AZD2171

  • DrugCediranib Maleate

    Given PO

    Also known as: AZD2171, AZD2171 Maleate, Recentin

  • ProcedureComputed Tomography

    Undergo CT

    Also known as: 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

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI

    Also known as: 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

  • DrugOlaparib

    Given PO

    Also known as: AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, Lynparza, Olanib, Olaparix, PARP Inhibitor AZD2281

  • DrugPaclitaxel

    Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • DrugPegylated Liposomal Doxorubicin Hydrochloride

    Given IV

    Also known as: ATI-0918, Caelyx, Dox-SL, Doxil, Doxilen, Doxorubicin HCl Liposomal, Doxorubicin HCl Liposome, Doxorubicin Hydrochloride Liposome, Doxorubicin Liposomal, 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

  • OtherQuestionnaire Administration

    Ancillary studies

  • DrugTopotecan

    Given IV

    Also known as: Hycamptamine, Topotecan Lactone

  • DrugTopotecan Hydrochloride

    Given IV

    Also known as: Evotopin, Hycamptamine, Hycamtin, Nogitecan Hydrochloride, Potactasol, SKF S 104864 A, SKF S-104864-A, SKF S104864A, Topotec, Topotecan HCl, topotecan hydrochloride (oral)

06

What researchers measure

Primary outcomes

  1. Progression-free Survival (PFS) (Phase II Only)

    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. Disease 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).

    Time frame: 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.

  2. Progression-free Survival (PFS) (Phase III Only)

    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. Disease 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).

    Time frame: 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.

  3. Overall Survival (OS) (Phase III Only)

    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.

    Time frame: Time from study enrollment to death due to any cause, assessed up to 5 years

Secondary outcomes

  1. Objective Response Rate (Complete Response and Partial Response) (Phase II Only)

    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. A 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.

    Time frame: Up to 5 years

  2. Objective Response Rate (Complete Response and Partial Response for Phase III Only)

    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. A 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.

    Time frame: Up to 5 years

  3. Incidence of Grade 3 (or Higher) Adverse Events

    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.

    Time frame: Up to 5 years

Other outcomes

  1. Patient-reported Scores of Disease-related Symptoms

    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).

    Time frame: Up to 5 years

  2. Gene Mutations Assessed BROCA-HR

    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).

    Time frame: Up to 5 years

  3. Change in Circulating Endothelial Cell Levels

    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.

    Time frame: Baseline up to 5 years

  4. Biomarkers in Plasma Angiome

    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.

    Time frame: Up to 5 years

07

Results

Posted May 6, 2025

Participant flow

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.

Participant flow — Overall Study
MilestoneArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Started17316717052587
Completed1241461390356
Not completed49213152231
Withdrew: Adverse event0000111
Withdrew: Withdrawal by subject3015160000
Withdrew: Still on treatment0010000
Withdrew: Other reasons196140110
Withdrew: Arm 4 discontinued00052000
Withdrew: Never treated0000010

Outcome measures

PrimaryProgression-free Survival (PFS) (Phase II Only)

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. Disease 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).

Time frame:
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.
Reported as:
Median · Months
Progression-free Survival (PFS) (Phase II Only)
MonthsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)
Progression-free Survival (PFS) (Phase II Only)2.3 (2.1 to 4.2)6.2 (3.9 to 8.2)3.4 (2.3 to 4.8)2.3 (2.0 to 2.8)
Statistical analysis
  • Arm I (Reference Regimen) vs Arm II (Cediranib Maleate, Olaparib) · Hazard ratio (hr): 0.649 · 95% CI 0.424 to 0.995The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.
  • Arm I (Reference Regimen) vs Arm III (Cediranib Maleate) · Hazard ratio (hr): 0.832 · 95% CI 0.539 to 1.284The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.
  • Arm I (Reference Regimen) vs Arm IV (Olaparib) (Phase II Only) · Hazard ratio (hr): 1.149 · 95% CI 0.745 to 1.773The hazard ratio estimate compares Olaparib to chemotherapy. If Olaparib is superior, the hazard ratio is \<1.0.
PrimaryProgression-free Survival (PFS) (Phase III Only)

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. Disease 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).

Time frame:
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.
Reported as:
Median · months
Progression-free Survival (PFS) (Phase III Only)
monthsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm V: (Arm 1 Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Progression-free Survival (PFS) (Phase III Only)3.4 (2.4 to 4.3)5.2 (4.2 to 6.2)4.0 (3.2 to 4.3)4.2 (2.1 to NA)5.3 (2.5 to 12.6)4.1 (2.3 to 4.8)
Statistical analysis
  • Arm I (Reference Regimen) vs Arm II (Cediranib Maleate, Olaparib) · Log Rank · p = 0.145 (The log rank test was stratified by the factors provided at randomization) · Hazard ratio (hr): 0.796 · 98% CI 0.597 to 1.060The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.
  • Arm I (Reference Regimen) vs Arm III (Cediranib Maleate) · Log Rank · p = 1.0 · Hazard ratio (hr): 0.972 · 98% CI 0.726 to 1.00The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.
PrimaryOverall Survival (OS) (Phase III Only)

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.

Time frame:
Time from study enrollment to death due to any cause, assessed up to 5 years
Reported as:
Median · months
Overall Survival (OS) (Phase III Only)
monthsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Overall Survival (OS) (Phase III Only)13.6 (11.6 to 15.8)12.8 (10.1 to 15.3)10.5 (9.1 to 12.3)14.9 (10.4 to NA)18.0 (2.8 to NA)5.8 (3.6 to 17.5)
Statistical analysis
  • Arm I (Reference Regimen) vs Arm II (Cediranib Maleate, Olaparib) · Hazard ratio (hr): 1.027 · 98% CI 0.771 to 1.368The hazard ratio estimate compares Cediranib and Olaparib to chemotherapy. If Cediranib and Olaparib is superior, the hazard ratio is \<1.0.
  • Arm I (Reference Regimen) vs Arm III (Cediranib Maleate) · Hazard ratio (hr): 1.060 · 98% CI 0.795 to 1.413The hazard ratio estimate compares Cediranib to chemotherapy. If Cediranib is superior, the hazard ratio is \<1.0.
SecondaryObjective Response Rate (Complete Response and Partial Response) (Phase II Only)

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. A 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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
ParticipantsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)41793
SecondaryObjective Response Rate (Complete Response and Partial Response for Phase III Only)

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. A 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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Objective Response Rate (Complete Response and Partial Response for Phase III Only)
ParticipantsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Objective Response Rate (Complete Response and Partial Response for Phase III Only)153223032
SecondaryIncidence of Grade 3 (or Higher) Adverse Events

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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Incidence of Grade 3 (or Higher) Adverse Events
ParticipantsArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V: (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Incidence of Grade 3 (or Higher) Adverse Events8812912624345
Other pre-specifiedPatient-reported Scores of Disease-related Symptoms

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).

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedGene Mutations Assessed BROCA-HR

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).

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedChange in Circulating Endothelial Cell Levels

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.

Time frame:
Baseline up to 5 years

Results for this outcome have not been posted.

Other pre-specifiedBiomarkers in Plasma Angiome

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.

Time frame:
Up to 5 years

Results for this outcome have not been posted.

Adverse events

Collected over Up to 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Reference Regimen)137/173 (79.2%)12/156 (7.7%)151/156 (96.8%)
Arm II (Cediranib Maleate, Olaparib)145/167 (86.8%)21/163 (12.9%)162/163 (99.4%)
Arm III (Cediranib Maleate)143/170 (84.1%)19/162 (11.7%)162/162 (100%)
Arm IV (Olaparib) (Phase II Only)45/52 (86.5%)14/49 (28.6%)46/49 (93.9%)
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)2/5 (40%)0/5 (0%)5/5 (100%)
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)5/8 (62.5%)0/7 (0%)7/7 (100%)
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)6/7 (85.7%)0/7 (0%)7/7 (100%)
Most frequent serious events
Showing 10 of 75
Most frequent serious events
EventArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
AnemiaBlood and lymphatic system disorders1/1560/1630/1625/490/50/70/7
NauseaGastrointestinal disorders2/1564/1633/1623/490/50/70/7
VomitingGastrointestinal disorders1/1563/1634/1623/490/50/70/7
Abdominal painGastrointestinal disorders3/1564/1634/1622/490/50/70/7
Ileal obstructionGastrointestinal disorders0/1560/1630/1622/490/50/70/7
IleusGastrointestinal disorders0/1561/1631/1622/490/50/70/7
Thromboembolic eventVascular disorders1/1560/1631/1622/490/50/70/7
Abdominal distensionGastrointestinal disorders1/1560/1630/1621/490/50/70/7
AscitesGastrointestinal disorders0/1560/1630/1621/490/50/70/7
Rectal hemorrhageGastrointestinal disorders0/1560/1630/1621/490/50/70/7
Most frequent other events
Showing 10 of 350
Most frequent other events
EventArm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
HypertensionVascular disorders21/156106/163128/1625/490/52/76/7
DiarrheaGastrointestinal disorders34/156122/163124/16213/491/55/75/7
FatigueGeneral disorders84/156124/163104/16228/490/51/70/7
NauseaGastrointestinal disorders77/156111/16391/16234/491/52/72/7
Neutrophil count decreasedInvestigations54/15623/16312/1624/493/52/71/7
MalaiseGeneral disorders1/1563/1631/1621/490/53/74/7
AnorexiaMetabolism and nutrition disorders38/15664/16368/16221/491/51/74/7
ProteinuriaRenal and urinary disorders8/15621/16319/1623/491/52/74/7
AnemiaBlood and lymphatic system disorders65/15635/16322/16227/491/51/71/7
VomitingGastrointestinal disorders32/15678/16359/16216/491/50/71/7

Baseline characteristics

All Randomized Subjects

Age, Customized
Age, Customized(Participants)Arm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)Total
20-29 years11010003
30-39 years41000005
40-49 years91414411144
50-59 years41343613122129
60-69 years63607222033223
70-79 years48484511321158
>= 80 years793100020
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)Total
Female17316717052587582
Male00000000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)Total
Hispanic or Latino663400019
Not Hispanic or Latino16115716546587549
Unknown or Not Reported642200014
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Reference Regimen)Arm II (Cediranib Maleate, Olaparib)Arm III (Cediranib Maleate)Arm IV (Olaparib) (Phase II Only)Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)Total
American Indian or Alaska Native12300006
Asian191211058762
Native Hawaiian or Other Pacific Islander00020002
Black or African American11611400032
White13514214245000464
More than one race00000000
Unknown or Not Reported753100016
08

Study locations

398 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Sutter Auburn Faith Hospital
    Auburn, California 95602, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Mercy San Juan Medical Center
    Carmichael, California 95608, United States
  • Mercy Cancer Center - Elk Grove
    Elk Grove, California 95758, United States
  • Marin Cancer Care Inc
    Greenbrae, California 94904, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
    Mountain View, California 94040, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California 94301, United States
  • Mercy Cancer Center - Rocklin
    Rocklin, California 95765, United States
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
  • Kaiser Permanente Downtown Commons
    Sacramento, California 95814, United States
  • Mercy Cancer Center - Sacramento
    Sacramento, California 95816, United States
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Kaiser Permanente Sacramento Medical Center
    Sacramento, California 95825, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Pacific Central Coast Health Center-San Luis Obispo
    San Luis Obispo, California 93401, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California 95065, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California 95403, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California 94086, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Woodland Memorial Hospital
    Woodland, California 95695, United States
  • UCHealth University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
  • Kaiser Permanente-Franklin
    Denver, Colorado 80205, United States
  • Rocky Mountain Cancer Centers-Rose
    Denver, Colorado 80220, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • UCHealth Highlands Ranch Hospital
    Highlands Ranch, Colorado 80129, United States
  • Kaiser Permanente-Rock Creek
    Lafayette, Colorado 80026, United States
  • Kaiser Permanente-Lone Tree
    Lone Tree, Colorado 80124, United States
  • Danbury Hospital
    Danbury, Connecticut 06810, United States
  • Smilow Cancer Hospital Care Center-Fairfield
    Fairfield, Connecticut 06824, United States
  • Hartford Hospital
    Hartford, Connecticut 06102, United States
  • Smilow Cancer Hospital Care Center at Saint Francis
    Hartford, Connecticut 06105, United States
  • Middlesex Hospital
    Middletown, Connecticut 06457, United States
  • The Hospital of Central Connecticut
    New Britain, Connecticut 06050, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Norwalk Hospital
    Norwalk, Connecticut 06856, United States
  • Smilow Cancer Hospital Care Center-Trumbull
    Trumbull, Connecticut 06611, United States
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
  • Christiana Care Health System-Christiana Hospital
    Newark, Delaware 19718, United States
  • Sibley Memorial Hospital
    Washington D.C., District of Columbia 20016, United States
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida 32610, United States
  • Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • Orlando Health Cancer Institute
    Orlando, Florida 32806, United States
  • Sarasota Memorial Hospital
    Sarasota, Florida 34239, United States
  • Emory University Hospital Midtown
    Atlanta, Georgia 30308, United States
  • Piedmont Hospital
    Atlanta, Georgia 30309, United States
  • Emory University Hospital/Winship Cancer Institute
    Atlanta, Georgia 30322, United States
  • Northside Hospital
    Atlanta, Georgia 30342, United States
  • Augusta University Medical Center
    Augusta, Georgia 30912, United States
  • WellStar Cobb Hospital
    Austell, Georgia 30106, United States
  • WellStar Health System Inc
    Marietta, Georgia 30060, United States
  • Wellstar Kennestone Hospital
    Marietta, Georgia 30060, United States
  • WellStar North Fulton Hospital
    Roswell, Georgia 30076, United States
  • Memorial Health University Medical Center
    Savannah, Georgia 31404, United States
  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    Savannah, Georgia 31405, United States
  • WellStar Vinings Health Park
    Smyrna, Georgia 30080, United States
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho 83619, United States
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho 83642, United States
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho 83687, United States
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • John H Stroger Jr Hospital of Cook County
    Chicago, Illinois 60612, United States
  • Rush MD Anderson Cancer Center
    Chicago, Illinois 60612, United States
  • UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
    Chicago, Illinois 60657, United States
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
  • NorthShore University HealthSystem-Evanston Hospital
    Evanston, Illinois 60201, United States
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
  • NorthShore University HealthSystem-Glenbrook Hospital
    Glenview, Illinois 60026, United States
  • NorthShore University HealthSystem-Highland Park Hospital
    Highland Park, Illinois 60035, United States
  • Sudarshan K Sharma MD Limited-Gynecologic Oncology
    Hinsdale, Illinois 60521, United States
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois 62269, United States
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States

Showing the first 100 of 398 sites across 5 countries.

09

References and documents

Publications

  • 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. PubMed 39361946 ↗

Study documents

  • Protocol and statistical analysis plan · Jul 27, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

2 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
Show 1 removed
  • West Virginia University Charleston Division · Charleston, United States
Oct 1, 2026
Show all 2 updates
  1. Oct 1, 2026
    1 site added, 1 site removed
    Show site
    • Vandalia Health/CAMC Institute for Academic Medicine · Charleston, United States
    Show 1 removed
    • West Virginia University Charleston Division · Charleston, United States
  2. Sep 29, 2026
    Minor edits only
    + 3 other changes: verification date, site details and registry notes

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT02502266
Lead sponsor
National Cancer Institute (NCI)
Collaborators
Canadian Cancer Trials Group, NRG Oncology
Responsible party
Sponsor
First posted
Jul 20, 2015
Start date
May 3, 2016
Primary completion
Jun 12, 2023
Completion
Mar 4, 2027 (estimated)
Results posted
May 6, 2025
Last update
Oct 1, 2026

Study contacts

Jung-min Lee
principal investigator · NRG Oncology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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