Ovarian Cancer Clinical Trial

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Summary

The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone.

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Full Description

Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world [ROW]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown).

Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator.

The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
High-grade serous adenocarcinoma
Willing to undergo testing for gBRCA.
Adequate hematologic, renal, and hepatic function.
Neuropathy (sensory and motor) less than or equal to Grade 1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.

Exclusion Criteria:

Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
Received prior chemotherapy for any abdominal or pelvic tumor.
Clinically significant uncontrolled condition(s).
Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.
History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1.

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1140

Study ID:

NCT02470585

Recruitment Status:

Terminated

Sponsor:

AbbVie

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There are 200 Locations for this study

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University of Alabama at Birmingham - Main /ID# 138087
Birmingham Alabama, 35233, United States
Tennessee Valley Gyn-Onc /ID# 139548
Huntsville Alabama, 35805, United States
University of South Alabama /ID# 138091
Mobile Alabama, 36604, United States
Alaska Womens Cancer Care /ID# 138231
Anchorage Alaska, 99508, United States
Arizona Oncology Associates, PC-HOPE /ID# 142002
Tucson Arizona, 85711, United States
Arizona Oncology Associates, PC-HOPE /ID# 143805
Tucson Arizona, 85711, United States
Arizona Oncology Associates, PC-HOPE /ID# 143806
Tucson Arizona, 85711, United States
Arizona Oncology Associates, PC-HOPE /ID# 143808
Tucson Arizona, 85711, United States
University of Arizona Cancer Center - North Campus /ID# 138084
Tucson Arizona, 85719, United States
University of Arizona Cancer Center - North Campus /ID# 139495
Tucson Arizona, 85719, United States
University of Arkansas for Medical Sciences /ID# 138253
Little Rock Arkansas, 72205, United States
John Muir Medical Center /ID# 139618
Concord California, 94520, United States
Ucsd /Id# 140323
La Jolla California, 92093, United States
Long Beach Memorial Medical Ct /ID# 147526
Long Beach California, 90806, United States
Kaiser Permanente /ID# 141305
Los Angeles California, 90027, United States
University of California, Los Angeles /ID# 138179
Los Angeles California, 90095, United States
Medical Oncology Care Assoc /ID# 139498
Orange California, 92868, United States
Univ CA, Irvine Med Ctr /ID# 139613
Orange California, 92868, United States
UC Davis Comprehensive Cancer Center - Main /ID# 144439
Sacramento California, 95817, United States
California Pacific Medical Ctr /ID# 138177
San Francisco California, 94115, United States
Kaiser Permanente - San Francisco /ID# 142051
San Francisco California, 94115, United States
Univ California, San Francisco /ID# 138178
San Francisco California, 94143, United States
Kaiser Permanente-Santa Clara /ID# 142053
Santa Clara California, 95051, United States
Stanford University School of Med /ID# 139450
Stanford California, 94305, United States
Palo Alto Medical Foundation /ID# 139452
Sunnyvale California, 94086, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 139492
Vallejo California, 94589, United States
Kaiser Permanente- Walnut Creek /ID# 142052
Walnut Creek California, 94596, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499
Aurora Colorado, 80014, United States
Univ of Colorado Cancer Center /ID# 138016
Aurora Colorado, 80045, United States
Hartford Healthcare /ID# 138184
New Britain Connecticut, 6053, United States
Yale University /ID# 138056
New Haven Connecticut, 06510, United States
University of Miami /ID# 139457
Miami Florida, 33136, United States
Women's Cancer Associates /ID# 140321
Saint Petersburg Florida, 33701, United States
Sarasota Memorial Health Care /ID# 138180
Sarasota Florida, 34239, United States
Moffitt Cancer Center /ID# 138061
Tampa Florida, 33612, United States
Georgia Regents University /ID# 138085
Augusta Georgia, 30912, United States
IACT Health /ID# 138058
Columbus Georgia, 31904, United States
Memorial Health Univ Med Ctr /ID# 138019
Savannah Georgia, 31404, United States
St. Joseph's/Candler /ID# 138090
Savannah Georgia, 31405, United States
The Queens Medical Center /ID# 141709
Honolulu Hawaii, 96813, United States
Kapiolani Medical Center /ID# 140319
Honolulu Hawaii, 96826, United States
Rush University Medical Center /ID# 143491
Chicago Illinois, 60612, United States
University of Chicago /ID# 139612
Chicago Illinois, 60637, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 139451
Evanston Illinois, 60201, United States
Sharma, Hinsdale, IL /ID# 140326
Hinsdale Illinois, 60521, United States
Advocate Lutheran General Hosp /ID# 139489
Park Ridge Illinois, 60068, United States
Indiana Univ School Medicine /ID# 139610
Indianapolis Indiana, 46202, United States
Saint Vincent /ID# 139537
Indianapolis Indiana, 46260, United States
McFarland Clinic, PC /ID# 139455
Ames Iowa, 50010, United States
University of Iowa Hospitals and Clinics /ID# 138082
Iowa City Iowa, 52242, United States
Univ Kansas Med Ctr /ID# 140322
Kansas City Kansas, 66160, United States
Baptist Health Lexington /ID# 139542
Lexington Kentucky, 40503, United States
University of Kentucky Chandler Medical Center /ID# 138060
Lexington Kentucky, 40536, United States
Norton Cancer Institute /ID# 139567
Louisville Kentucky, 40202, United States
MMP Women's Health /ID# 139544
Portland Maine, 04102, United States
Greater Baltimore Medical Ctr /ID# 138049
Baltimore Maryland, 21204, United States
Sinai Hospital of Baltimore /ID# 141306
Baltimore Maryland, 21215, United States
Weinberg Cancer Inst Franklin /ID# 138235
Rossville Maryland, 21237, United States
Baystate Medical Center /ID# 139456
Springfield Massachusetts, 01199, United States
UMass Memorial Medical Center /ID# 139458
Worcester Massachusetts, 01655, United States
Wayne State University /ID# 139601
Detroit Michigan, 48201, United States
Henry Ford Health System /ID# 139536
Detroit Michigan, 48202, United States
William Beaumont Hospital /ID# 139550
Royal Oak Michigan, 48073, United States
Mayo Clinic - Rochester /ID# 139565
Rochester Minnesota, 55905, United States
Mmcorc /Id# 139534
Saint Louis Park Minnesota, 55416, United States
St. Dominic Hospital /ID# 138241
Jackson Mississippi, 39216, United States
Ellis Fischel Cancer Center /ID# 139571
Columbia Missouri, 65212, United States
Washington University-School of Medicine /ID# 138089
Saint Louis Missouri, 63110, United States
Cancer Research For the Ozarks /ID# 139538
Springfield Missouri, 65804, United States
Ferrell-Duncan Clinic /ID# 143484
Springfield Missouri, 65807, United States
Nebraska Methodist Hospital /ID# 139600
Omaha Nebraska, 68114, United States
Womens Cancer Center of Nevada /ID# 138092
Las Vegas Nevada, 89169, United States
Renown Regional Medical Center /ID# 138237
Reno Nevada, 89502, United States
Dartmouth-Hitchcock Medical Center /ID# 139502
Lebanon New Hampshire, 03756, United States
MD Anderson Cancer Ctr at Coop /ID# 139616
Camden New Jersey, 08103, United States
Hackensack Univ Med Ctr /ID# 143776
Hackensack New Jersey, 07601, United States
University of New Mexico /ID# 144220
Albuquerque New Mexico, 87102, United States
SW Gynecologic Oncology Assoc /ID# 147097
Albuquerque New Mexico, 87106, United States
Women's Cancer Care Associates /ID# 138234
Albany New York, 12208, United States
Montefiore Medical Center /ID# 139585
Bronx New York, 10461, United States
SUNY Downstate Medical Center /ID# 139533
Brooklyn New York, 11203, United States
Roswell Park Comprehensive Cancer Center /ID# 138052
Buffalo New York, 14263, United States
Northwell Health /ID# 139572
Lake Success New York, 11042, United States
Icahn School of Med Mt. Sinai /ID# 139617
New York New York, 10029, United States
Columbia University Medical Center /ID# 138252
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center /ID# 138017
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center /ID# 154464
New York New York, 10065, United States
SUNY Upstate Medical University - Downtown /ID# 139513
Syracuse New York, 13210, United States
Hope Womens Cancer Centers /ID# 139614
Asheville North Carolina, 28816, United States
Univ NC Chapel Hill /ID# 138547
Chapel Hill North Carolina, 27514, United States
Atrium Health Carolinas Medical Center /ID# 139568
Charlotte North Carolina, 28203, United States
Presbyterian Cancer Center /ID# 139590
Charlotte North Carolina, 28204, United States
Duke University Medical Center /ID# 138048
Durham North Carolina, 27710, United States
Wake Forest Baptist Medical Center /ID# 139588
Winston-Salem North Carolina, 27157, United States
University of Cincinnati /ID# 139619
Cincinnati Ohio, 45267, United States
Univ Hosp Cleveland /ID# 139615
Cleveland Ohio, 44106, United States
Fairview Hospital /ID# 144403
Cleveland Ohio, 44111, United States
Cleveland Clinic Main Campus /ID# 139501
Cleveland Ohio, 44195, United States
The Ohio State University - Columbus /ID# 138053
Columbus Ohio, 43210, United States
Columbus NCORP /ID# 139587
Columbus Ohio, 43215, United States
Womens Cancer Center /ID# 138062
Kettering Ohio, 45429, United States
Hillcrest Hospital /ID# 144404
Mayfield Heights Ohio, 44124, United States
Univ Oklahoma HSC /ID# 138020
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists /ID# 138059
Tulsa Oklahoma, 74146, United States
Willamette Valley Cancer Institute /ID# 140318
Eugene Oregon, 97401, United States
Kaiser Permanente, NW /ID# 138249
Portland Oregon, 97227, United States
Abington Memorial Hospital /ID# 138086
Abington Pennsylvania, 19001, United States
University of Pennsylvania /ID# 140079
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University /ID# 138239
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center /ID# 149479
Philadelphia Pennsylvania, 19111, United States
University of Pittsburgh MC /ID# 138054
Pittsburgh Pennsylvania, 15260, United States
Reading Hospital /ID# 138057
Reading Pennsylvania, 19611, United States
Women and Infants Hospital /ID# 138083
Providence Rhode Island, 02905, United States
Medical University of South Carolina /ID# 138181
Charleston South Carolina, 29425, United States
Sanford Research/USD /ID# 139624
Sioux Falls South Dakota, 57104, United States
Chattanoogas Program in Womens /ID# 139545
Chattanooga Tennessee, 37403, United States
Texas Oncology - Austin Central /ID# 143817
Austin Texas, 78731, United States
Texas Oncology - South Austin /ID# 143818
Austin Texas, 78745, United States
Texas Oncology - Bedford /ID# 143814
Bedford Texas, 76022, United States
Texas Oncology - Medical City Dallas /ID# 143809
Dallas Texas, 75230, United States
Texas Oncology - Medical City Dallas /ID# 143812
Dallas Texas, 75230, United States
Texas Oncology - Forth Worth /ID# 143811
Fort Worth Texas, 76104, United States
Houston Methodist Hospital - Scurlock Tower /ID# 138232
Houston Texas, 77030, United States
Memorial Hermann Hospital /ID# 138238
Houston Texas, 77030, United States
Texas Oncology - The Woodlands /ID# 142003
The Woodlands Texas, 77380, United States
Texas Oncology - Tyler /ID# 143810
Tyler Texas, 75702, United States
University of Utah /ID# 138250
Salt Lake City Utah, 84112, United States
University of Vermont Medical Center /ID# 138251
Burlington Vermont, 05401, United States
University of Virginia /ID# 138088
Charlottesville Virginia, 22908, United States
Carilion Roanoke Memorial Hosp /ID# 139602
Roanoke Virginia, 24014, United States
Skagit Valley Medical Center /ID# 139586
Mount Vernon Washington, 98273, United States
MultiCare Regional Cancer Ctr /ID# 149872
Puyallup Washington, 93872, United States
Multicare Institute for Research and Innovation /ID# 143485
Tacoma Washington, 98405, United States
HSHS St. Vincent Hospital /ID# 139453
Green Bay Wisconsin, 54301, United States
Froedtert & the Medical College of Wisconsin /ID# 139449
Milwaukee Wisconsin, 53226, United States
Coffs Harbour Health Campus /ID# 145132
Coffs Harbour New South Wales, 2450, Australia
Gosford Hospital /ID# 145299
Gosford New South Wales, 2250, Australia
St George Hospital /ID# 145138
Kogarah New South Wales, 2217, Australia
Newcastle Private Hospital /ID# 145834
Lambton Heights New South Wales, 2305, Australia
The Prince of Wales Hospital /ID# 145134
Randwick New South Wales, 2031, Australia
Northern Cancer Institute /ID# 145681
St Leonards New South Wales, 2065, Australia
Calvary Mater Newcastle /ID# 145139
Waratah New South Wales, 2298, Australia
Westmead Hospital /ID# 145137
Westmead New South Wales, 2145, Australia
Southern Medical Day Care Ctr /ID# 145133
Wollongong New South Wales, 2500, Australia
The Townsville Hospital /ID# 149163
Douglas Queensland, 4814, Australia
Royal Brisbane and Women's Hospital /ID# 145135
Herston Queensland, 4029, Australia
Icon Cancer Centre /ID# 148208
South Brisbane Queensland, 4101, Australia
Mater Misericordiae Limited /ID# 145682
South Brisbane Queensland, 4101, Australia
Royal Adelaide Hospital /ID# 150071
Adelaide South Australia, 5000, Australia
Monash Health /ID# 145297
Clayton Victoria, 3168, Australia
Cabrini Health /ID# 145142
Malvern Victoria, 3144, Australia
Royal Womens Hospital /ID# 145136
Parkville Victoria, 3052, Australia
Sir Charles Gairdner Hospital /ID# 145140
Nedlands Western Australia, 6009, Australia
St. John of God Subiaco Hosp /ID# 147742
Subiaco Western Australia, 6008, Australia
Hc Ufmg /Id# 137156
Belo Horizonte Minas Gerais, 30130, Brazil
Hospital Sao Lucas da PUCRS /ID# 137157
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Hospital de Cancer de Barretos /ID# 137121
Barretos Sao Paulo, 14784, Brazil
Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120
São Paulo Sao Paulo, 01317, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155
Rio de Janeiro , 20231, Brazil
Vejle Sygehus /ID# 137262
Vejle Syddanmark, 7100, Denmark
Regionshospitalet Herning /ID# 137260
Herning , 7400, Denmark
Rambam Health Care Campus /ID# 137434
Haifa , 31096, Israel
The Lady Davis Carmel MC /ID# 137537
Haifa , 34362, Israel
Shaare Zedek Medical Center /ID# 137435
Jerusalem , 91031, Israel
Meir Medical Center /ID# 139397
Kfar Saba , 44281, Israel
Sheba Medical Center /ID# 137436
Ramat Gan , 52621, Israel
Kaplan Medical Center /ID# 137536
Rehovot , 76100, Israel
Aichi Cancer Center Hospital /ID# 148398
Nagoya-shi Aichi, 464-8, Japan
National Hospital Organization Kyushu Cancer Center /ID# 149133
Fukuoka-shi Fukuoka, 811-1, Japan
Kurume University Hospital /ID# 148697
Kurume-shi Fukuoka, 830-0, Japan
Iwate Medical University Hospital /ID# 147721
Shiwa-gun Iwate, 028-3, Japan
Kumamoto University Hospital /ID# 154169
Kumamoto-shi Kumamoto, 860-8, Japan
Mie University Hospital /ID# 149169
Tsu-shi Mie, 514-8, Japan
Tohoku University Hospital /ID# 149818
Sendai-shi Miyagi, 980-8, Japan
Niigata University Medical & Dental Hospital /ID# 149488
Niigata-shi Niigata, 951-8, Japan
Kindai University Hospital /ID# 154947
Osaka-sayama Osaka, 58985, Japan
Shizuoka Cancer Center /ID# 147723
Sunto-gun Shizuoka, 411-8, Japan
The Cancer Institute Hosp JFCR /ID# 148436
Koto-ku Tokyo, 135-8, Japan
Keio University Hospital /ID# 148326
Shinjuku-ku Tokyo, 160-8, Japan
Yamagata University Hospital /ID# 153646
Yamagata-shi Yamagata, 990-9, Japan
Hyogo Cancer Center /ID# 148327
Akashi , 673-8, Japan
Kansai Rosai Hospital /ID# 149237
Amagasaki , 660-8, Japan
The Jikei Univ. Kashiwa Hosp. /ID# 149238
Kashiwa-shi , 277-0, Japan
St. Marianna Univ Hospital /ID# 149327
Kawasaki , 216-8, Japan
NHO Kure Medical Center and Ch /ID# 148569
Kure , 737-0, Japan
Shikoku Cancer Center /ID# 148382
Matsuyama , 791-0, Japan
Osaka International Cancer Institute /ID# 150778
Osaka , 541-8, Japan
Hokkaido Cancer Center /ID# 148570
Sapporo , 003-0, Japan
The Jikei University Hospital /ID# 148691
Tokyo , 105-8, Japan
National Cancer Center /ID# 139404
Goyang Gyeonggido, 10408, Korea, Republic of
Korea University Anam Hospital /ID# 136908
성북구 Gyeonggido, 02841, Korea, Republic of
Gangnam Severance Hospital /ID# 136835
Seoul Seoul Teugbyeolsi, 06273, Korea, Republic of
Samsung Medical Center /ID# 136834
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Seoul National University Hospital /ID# 136909
Seoul , 03080, Korea, Republic of
Asan Medical Center /ID# 136836
Seoul , 05505, Korea, Republic of
Auckland City Hospital /ID# 145123
Auckland , 1023, New Zealand
Uniwersyteckie C. Kliniczne /ID# 138021
Gdańsk , 80-21, Poland
Hospital Duran i Reynals /ID# 137298
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Univ Vall d'Hebron /ID# 137297
Barcelona , 08035, Spain
Hospital Clinic de Barcelona /ID# 137300
Barcelona , 08036, Spain
Hospital Clin Univ San Carlos /ID# 137402
Madrid , 28040, Spain
Hosp Univ 12 de Octubre /ID# 137299
Madrid , 28041, Spain
Hosp Univ Madrid Sanchinarro /ID# 137414
Madrid , 28050, Spain
Fundacion Inst Valenciano Onc /ID# 137403
Valencia , 46009, Spain
Norfolk and Norwich Univ Hosp /ID# 137969
Norwich Norfolk, NR4 7, United Kingdom
Beatson west of scotland cancer center /ID# 137965
Glasgow Scotland, G12 0, United Kingdom
Ninewells Hospital /ID# 137967
Dundee , DD1 9, United Kingdom
James Paget University Hosp /ID# 137970
Great Yarmouth , NR31 , United Kingdom
Imanova Limited, Hammersmith Hospital /ID# 137966
London , W12 0, United Kingdom
Oxford Univ Hosp NHS Trust /ID# 137973
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

1140

Study ID:

NCT02470585

Recruitment Status:

Terminated

Sponsor:


AbbVie

How clear is this clinincal trial information?

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