Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
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)
4 other identifiers
interventional
582
5 countries
398
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2016
Longer than P75 for phase_2
398 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2023
CompletedResults Posted
Study results publicly available
May 6, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2027
ExpectedApril 29, 2026
March 1, 2026
7.1 years
July 17, 2015
October 11, 2024
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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).
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.
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).
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.
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 from study enrollment to death due to any cause, assessed up to 5 years
Secondary Outcomes (3)
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
Up to 5 years
Objective Response Rate (Complete Response and Partial Response for Phase III Only)
Up to 5 years
Incidence of Grade 3 (or Higher) Adverse Events
Up to 5 years
Other Outcomes (4)
Patient-reported Scores of Disease-related Symptoms
Up to 5 years
Gene Mutations Assessed BROCA-HR
Up to 5 years
Change in Circulating Endothelial Cell Levels
Baseline up to 5 years
- +1 more other outcomes
Study Arms (7)
Phase II Arm I (reference regimen)
ACTIVE COMPARATORPatients 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)
Phase II Arm II (cediranib maleate, olaparib)
EXPERIMENTALPatients 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.
Phase II Arm III (cediranib maleate)
EXPERIMENTALPatients 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.
Phase II Arm IV (olaparib)
EXPERIMENTALPatients 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 Arm I (reference regimen)
ACTIVE COMPARATORPatients 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)
Phase III Arm II (cediranib maleate, olaparib)
EXPERIMENTALPatients receive cediranib maleate PO and olaparib PO as in Phase II Arm II. Patients also undergo CT and MRI throughout the study.
Phase III Arm III (single-agent cediranib maleate)
EXPERIMENTALPatients 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.
Interventions
Undergo MRI
Given PO
Given PO
Given PO
Undergo CT
Given IV
Given IV
Given IV
Ancillary studies
Given IV
Eligibility Criteria
You may qualify if:
- 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)
- +9 more criteria
You may not qualify if:
- 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
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologycollaborator
- National Cancer Institute (NCI)lead
- Canadian Cancer Trials Groupcollaborator
Study Sites (398)
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
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, 46260, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Saint Elizabeth Healthcare Edgewood
Edgewood, Kentucky, 41017, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Hematology/Oncology Clinic PLLC
Baton Rouge, Louisiana, 70809, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Women's Cancer Care-Covington
Covington, Louisiana, 70433, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland, 21014, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
TidalHealth Richard A Henson Cancer Institute
Ocean Pines, Maryland, 21811, United States
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
UMass Memorial Medical Center - Memorial Division
Worcester, Massachusetts, 01605, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan, 48183, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota, 55369, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Mercy Hospital Joplin
Joplin, Missouri, 64804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, 68803, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Dartmouth Cancer Center - Nashua
Nashua, New Hampshire, 03063, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Jersey Shore Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees Township, New Jersey, 08043, United States
Southwest Gynecologic Oncology Associates Inc
Albuquerque, New Mexico, 87106, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Memorial Medical Center-Las Cruces
Las Cruces, New Mexico, 88011, United States
Women's Cancer Care Associates LLC
Albany, New York, 12208, United States
State University of New York Downstate Medical Center
Brooklyn, New York, 11203, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
AdventHealth Infusion Center Asheville
Asheville, North Carolina, 28803, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
AdventHealth Infusion Center Haywood
Clyde, North Carolina, 28721, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
AdventHealth Hendersonville
Hendersonville, North Carolina, 28792, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
TriHealth Cancer Institute-Westside
Cincinnati, Ohio, 45247, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
ProMedica Flower Hospital
Sylvania, Ohio, 43560, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio, 43606, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Legacy Mount Hood Medical Center
Gresham, Oregon, 97030, United States
Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon, 97210, United States
Legacy Meridian Park Hospital
Tualatin, Oregon, 97062, United States
Jefferson Abington Hospital
Abington, Pennsylvania, 19001, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Ephrata Cancer Center
Ephrata, Pennsylvania, 17522, United States
Ephrata Community Hospital
Ephrata, Pennsylvania, 17522, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
WellSpan Medical Oncology and Hematology
Hanover, Pennsylvania, 17331, United States
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, 17109, United States
Sechler Family Cancer Center
Lebanon, Pennsylvania, 17042, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
UPMC Susquehanna
Williamsport, Pennsylvania, 17701, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
South Carolina Cancer Specialists PC
Hilton Head Island, South Carolina, 29926-3827, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Covenant Health Cancer Centers
Knoxville, Tennessee, 37916, United States
Covenant Health Cancer Centers - West
Knoxville, Tennessee, 37932, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Methodist Willowbrook Hospital
Houston, Texas, 77070, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Northwest
Seattle, Washington, 98133, United States
Women's Cancer Center of Seattle
Seattle, Washington, 98133, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
West Virginia University Charleston Division
Charleston, West Virginia, 25304, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701, United States
Monongalia Hospital
Morgantown, West Virginia, 26505, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Ascension Saint Elizabeth Hospital
Appleton, Wisconsin, 54915, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, 53105, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Aurora Health Center-Fond du Lac
Fond du Lac, Wisconsin, 54937, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, 53022, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, 54143, United States
Saint Vincent Hospital Cancer Center at Marinette
Marinette, Wisconsin, 54143, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon, Wisconsin, 53097, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209, United States
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee, Wisconsin, 53211, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Ascension Mercy Hospital
Oshkosh, Wisconsin, 54904, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, 53406, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, United States
Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin, 54481, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
Aurora Medical Center in Summit
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, 53226, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, 53227, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Algoma District Cancer Program Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
CHUM - Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Ehime University Hospital
Tōon, Ehime, 791-0295, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kagoshima City Hospital
Kagoshima, Kagoshima-ken, 890-8760, Japan
The Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Kindai University
Osaka, 589 8511, Japan
Saitama Medical University International Medical Center
Saitama, 350-1298, Japan
National Cancer Center Hospital
Tokyo, 104 0045, Japan
Centro Comprensivo de Cancer de UPR
San Juan, 00927, Puerto Rico
Keimyung University-Dongsan Medical Center
Dalseo-gu, Daegu, 42601, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, 463-707, South Korea
Gachon University Gil Hospital
Incheon, 405-760, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, 134-727, South Korea
Korea Cancer Center Hospital
Seoul, 139-706, South Korea
Related Publications (1)
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.
PMID: 39361946DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christopher Purdy on behalf of Austin Miller, PhD
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Jung-min Lee
NRG Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 20, 2015
Study Start
May 3, 2016
Primary Completion
June 12, 2023
Study Completion (Estimated)
March 4, 2027
Last Updated
April 29, 2026
Results First Posted
May 6, 2025
Record last verified: 2026-03