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.
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.
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.
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There are 200 Locations for this study
Birmingham Alabama, 35233, United States
Huntsville Alabama, 35805, United States
Mobile Alabama, 36604, United States
Anchorage Alaska, 99508, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85711, United States
Tucson Arizona, 85719, United States
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Concord California, 94520, United States
La Jolla California, 92093, United States
Long Beach California, 90806, United States
Los Angeles California, 90027, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Orange California, 92868, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
San Francisco California, 94115, United States
San Francisco California, 94143, United States
Santa Clara California, 95051, United States
Stanford California, 94305, United States
Sunnyvale California, 94086, United States
Vallejo California, 94589, United States
Walnut Creek California, 94596, United States
Aurora Colorado, 80014, United States
Aurora Colorado, 80045, United States
New Britain Connecticut, 6053, United States
New Haven Connecticut, 06510, United States
Miami Florida, 33136, United States
Saint Petersburg Florida, 33701, United States
Sarasota Florida, 34239, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Columbus Georgia, 31904, United States
Savannah Georgia, 31404, United States
Savannah Georgia, 31405, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96826, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Hinsdale Illinois, 60521, United States
Park Ridge Illinois, 60068, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Ames Iowa, 50010, United States
Iowa City Iowa, 52242, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Portland Maine, 04102, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21215, United States
Rossville Maryland, 21237, United States
Springfield Massachusetts, 01199, United States
Worcester Massachusetts, 01655, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Royal Oak Michigan, 48073, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Jackson Mississippi, 39216, United States
Columbia Missouri, 65212, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Omaha Nebraska, 68114, United States
Las Vegas Nevada, 89169, United States
Reno Nevada, 89502, United States
Lebanon New Hampshire, 03756, United States
Camden New Jersey, 08103, United States
Hackensack New Jersey, 07601, United States
Albuquerque New Mexico, 87102, United States
Albuquerque New Mexico, 87106, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
Brooklyn New York, 11203, United States
Buffalo New York, 14263, United States
Lake Success New York, 11042, United States
New York New York, 10029, United States
New York New York, 10032, United States
New York New York, 10065, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Asheville North Carolina, 28816, United States
Chapel Hill North Carolina, 27514, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27710, United States
Winston-Salem North Carolina, 27157, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43215, United States
Kettering Ohio, 45429, United States
Mayfield Heights Ohio, 44124, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Eugene Oregon, 97401, United States
Portland Oregon, 97227, United States
Abington Pennsylvania, 19001, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15260, United States
Reading Pennsylvania, 19611, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57104, United States
Chattanooga Tennessee, 37403, United States
Austin Texas, 78731, United States
Austin Texas, 78745, United States
Bedford Texas, 76022, United States
Dallas Texas, 75230, United States
Dallas Texas, 75230, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84112, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Roanoke Virginia, 24014, United States
Mount Vernon Washington, 98273, United States
Puyallup Washington, 93872, United States
Tacoma Washington, 98405, United States
Green Bay Wisconsin, 54301, United States
Milwaukee Wisconsin, 53226, United States
Coffs Harbour New South Wales, 2450, Australia
Gosford New South Wales, 2250, Australia
Kogarah New South Wales, 2217, Australia
Lambton Heights New South Wales, 2305, Australia
Randwick New South Wales, 2031, Australia
St Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Westmead New South Wales, 2145, Australia
Wollongong New South Wales, 2500, Australia
Douglas Queensland, 4814, Australia
Herston Queensland, 4029, Australia
South Brisbane Queensland, 4101, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Malvern Victoria, 3144, Australia
Parkville Victoria, 3052, Australia
Nedlands Western Australia, 6009, Australia
Subiaco Western Australia, 6008, Australia
Belo Horizonte Minas Gerais, 30130, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Barretos Sao Paulo, 14784, Brazil
São Paulo Sao Paulo, 01317, Brazil
Rio de Janeiro , 20231, Brazil
Vejle Syddanmark, 7100, Denmark
Herning , 7400, Denmark
Haifa , 31096, Israel
Haifa , 34362, Israel
Jerusalem , 91031, Israel
Kfar Saba , 44281, Israel
Ramat Gan , 52621, Israel
Rehovot , 76100, Israel
Nagoya-shi Aichi, 464-8, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Kurume-shi Fukuoka, 830-0, Japan
Shiwa-gun Iwate, 028-3, Japan
Kumamoto-shi Kumamoto, 860-8, Japan
Tsu-shi Mie, 514-8, Japan
Sendai-shi Miyagi, 980-8, Japan
Niigata-shi Niigata, 951-8, Japan
Osaka-sayama Osaka, 58985, Japan
Sunto-gun Shizuoka, 411-8, Japan
Koto-ku Tokyo, 135-8, Japan
Shinjuku-ku Tokyo, 160-8, Japan
Yamagata-shi Yamagata, 990-9, Japan
Akashi , 673-8, Japan
Amagasaki , 660-8, Japan
Kashiwa-shi , 277-0, Japan
Kawasaki , 216-8, Japan
Kure , 737-0, Japan
Matsuyama , 791-0, Japan
Osaka , 541-8, Japan
Sapporo , 003-0, Japan
Tokyo , 105-8, Japan
Goyang Gyeonggido, 10408, Korea, Republic of
성ë¶êµ¬ Gyeonggido, 02841, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06273, Korea, Republic of
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Auckland , 1023, New Zealand
Gdańsk , 80-21, Poland
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28050, Spain
Valencia , 46009, Spain
Norwich Norfolk, NR4 7, United Kingdom
Glasgow Scotland, G12 0, United Kingdom
Dundee , DD1 9, United Kingdom
Great Yarmouth , NR31 , United Kingdom
London , W12 0, United Kingdom
Oxford , OX3 7, United Kingdom
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