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Brief Title: 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
Official Title: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study ID: NCT02470585
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham - Main /ID# 138087, Birmingham, Alabama, United States
Tennessee Valley Gyn-Onc /ID# 139548, Huntsville, Alabama, United States
University of South Alabama /ID# 138091, Mobile, Alabama, United States
Alaska Womens Cancer Care /ID# 138231, Anchorage, Alaska, United States
Arizona Oncology Associates, PC-HOPE /ID# 142002, Tucson, Arizona, United States
Arizona Oncology Associates, PC-HOPE /ID# 143805, Tucson, Arizona, United States
Arizona Oncology Associates, PC-HOPE /ID# 143806, Tucson, Arizona, United States
Arizona Oncology Associates, PC-HOPE /ID# 143808, Tucson, Arizona, United States
University of Arizona Cancer Center - North Campus /ID# 138084, Tucson, Arizona, United States
University of Arizona Cancer Center - North Campus /ID# 139495, Tucson, Arizona, United States
University of Arkansas for Medical Sciences /ID# 138253, Little Rock, Arkansas, United States
John Muir Medical Center /ID# 139618, Concord, California, United States
Ucsd /Id# 140323, La Jolla, California, United States
Long Beach Memorial Medical Ct /ID# 147526, Long Beach, California, United States
Kaiser Permanente /ID# 141305, Los Angeles, California, United States
University of California, Los Angeles /ID# 138179, Los Angeles, California, United States
Medical Oncology Care Assoc /ID# 139498, Orange, California, United States
Univ CA, Irvine Med Ctr /ID# 139613, Orange, California, United States
UC Davis Comprehensive Cancer Center - Main /ID# 144439, Sacramento, California, United States
California Pacific Medical Ctr /ID# 138177, San Francisco, California, United States
Kaiser Permanente - San Francisco /ID# 142051, San Francisco, California, United States
Univ California, San Francisco /ID# 138178, San Francisco, California, United States
Kaiser Permanente-Santa Clara /ID# 142053, Santa Clara, California, United States
Stanford University School of Med /ID# 139450, Stanford, California, United States
Palo Alto Medical Foundation /ID# 139452, Sunnyvale, California, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 139492, Vallejo, California, United States
Kaiser Permanente- Walnut Creek /ID# 142052, Walnut Creek, California, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499, Aurora, Colorado, United States
Univ of Colorado Cancer Center /ID# 138016, Aurora, Colorado, United States
Hartford Healthcare /ID# 138184, New Britain, Connecticut, United States
Yale University /ID# 138056, New Haven, Connecticut, United States
University of Miami /ID# 139457, Miami, Florida, United States
Women's Cancer Associates /ID# 140321, Saint Petersburg, Florida, United States
Sarasota Memorial Health Care /ID# 138180, Sarasota, Florida, United States
Moffitt Cancer Center /ID# 138061, Tampa, Florida, United States
Georgia Regents University /ID# 138085, Augusta, Georgia, United States
IACT Health /ID# 138058, Columbus, Georgia, United States
Memorial Health Univ Med Ctr /ID# 138019, Savannah, Georgia, United States
St. Joseph's/Candler /ID# 138090, Savannah, Georgia, United States
The Queens Medical Center /ID# 141709, Honolulu, Hawaii, United States
Kapiolani Medical Center /ID# 140319, Honolulu, Hawaii, United States
Rush University Medical Center /ID# 143491, Chicago, Illinois, United States
University of Chicago /ID# 139612, Chicago, Illinois, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 139451, Evanston, Illinois, United States
Sharma, Hinsdale, IL /ID# 140326, Hinsdale, Illinois, United States
Advocate Lutheran General Hosp /ID# 139489, Park Ridge, Illinois, United States
Indiana Univ School Medicine /ID# 139610, Indianapolis, Indiana, United States
Saint Vincent /ID# 139537, Indianapolis, Indiana, United States
McFarland Clinic, PC /ID# 139455, Ames, Iowa, United States
University of Iowa Hospitals and Clinics /ID# 138082, Iowa City, Iowa, United States
Univ Kansas Med Ctr /ID# 140322, Kansas City, Kansas, United States
Baptist Health Lexington /ID# 139542, Lexington, Kentucky, United States
University of Kentucky Chandler Medical Center /ID# 138060, Lexington, Kentucky, United States
Norton Cancer Institute /ID# 139567, Louisville, Kentucky, United States
MMP Women's Health /ID# 139544, Portland, Maine, United States
Greater Baltimore Medical Ctr /ID# 138049, Baltimore, Maryland, United States
Sinai Hospital of Baltimore /ID# 141306, Baltimore, Maryland, United States
Weinberg Cancer Inst Franklin /ID# 138235, Rossville, Maryland, United States
Baystate Medical Center /ID# 139456, Springfield, Massachusetts, United States
UMass Memorial Medical Center /ID# 139458, Worcester, Massachusetts, United States
Wayne State University /ID# 139601, Detroit, Michigan, United States
Henry Ford Health System /ID# 139536, Detroit, Michigan, United States
William Beaumont Hospital /ID# 139550, Royal Oak, Michigan, United States
Mayo Clinic - Rochester /ID# 139565, Rochester, Minnesota, United States
Mmcorc /Id# 139534, Saint Louis Park, Minnesota, United States
St. Dominic Hospital /ID# 138241, Jackson, Mississippi, United States
Ellis Fischel Cancer Center /ID# 139571, Columbia, Missouri, United States
Washington University-School of Medicine /ID# 138089, Saint Louis, Missouri, United States
Cancer Research For the Ozarks /ID# 139538, Springfield, Missouri, United States
Ferrell-Duncan Clinic /ID# 143484, Springfield, Missouri, United States
Nebraska Methodist Hospital /ID# 139600, Omaha, Nebraska, United States
Womens Cancer Center of Nevada /ID# 138092, Las Vegas, Nevada, United States
Renown Regional Medical Center /ID# 138237, Reno, Nevada, United States
Dartmouth-Hitchcock Medical Center /ID# 139502, Lebanon, New Hampshire, United States
MD Anderson Cancer Ctr at Coop /ID# 139616, Camden, New Jersey, United States
Hackensack Univ Med Ctr /ID# 143776, Hackensack, New Jersey, United States
University of New Mexico /ID# 144220, Albuquerque, New Mexico, United States
SW Gynecologic Oncology Assoc /ID# 147097, Albuquerque, New Mexico, United States
Women's Cancer Care Associates /ID# 138234, Albany, New York, United States
Montefiore Medical Center /ID# 139585, Bronx, New York, United States
SUNY Downstate Medical Center /ID# 139533, Brooklyn, New York, United States
Roswell Park Comprehensive Cancer Center /ID# 138052, Buffalo, New York, United States
Northwell Health /ID# 139572, Lake Success, New York, United States
Icahn School of Med Mt. Sinai /ID# 139617, New York, New York, United States
Columbia University Medical Center /ID# 138252, New York, New York, United States
Memorial Sloan Kettering Cancer Center /ID# 138017, New York, New York, United States
Memorial Sloan Kettering Cancer Center /ID# 154464, New York, New York, United States
SUNY Upstate Medical University - Downtown /ID# 139513, Syracuse, New York, United States
Hope Womens Cancer Centers /ID# 139614, Asheville, North Carolina, United States
Univ NC Chapel Hill /ID# 138547, Chapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center /ID# 139568, Charlotte, North Carolina, United States
Presbyterian Cancer Center /ID# 139590, Charlotte, North Carolina, United States
Duke University Medical Center /ID# 138048, Durham, North Carolina, United States
Wake Forest Baptist Medical Center /ID# 139588, Winston-Salem, North Carolina, United States
University of Cincinnati /ID# 139619, Cincinnati, Ohio, United States
Univ Hosp Cleveland /ID# 139615, Cleveland, Ohio, United States
Fairview Hospital /ID# 144403, Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 139501, Cleveland, Ohio, United States
The Ohio State University - Columbus /ID# 138053, Columbus, Ohio, United States
Columbus NCORP /ID# 139587, Columbus, Ohio, United States
Womens Cancer Center /ID# 138062, Kettering, Ohio, United States
Hillcrest Hospital /ID# 144404, Mayfield Heights, Ohio, United States
Univ Oklahoma HSC /ID# 138020, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists /ID# 138059, Tulsa, Oklahoma, United States
Willamette Valley Cancer Institute /ID# 140318, Eugene, Oregon, United States
Kaiser Permanente, NW /ID# 138249, Portland, Oregon, United States
Abington Memorial Hospital /ID# 138086, Abington, Pennsylvania, United States
University of Pennsylvania /ID# 140079, Philadelphia, Pennsylvania, United States
Thomas Jefferson University /ID# 138239, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center /ID# 149479, Philadelphia, Pennsylvania, United States
University of Pittsburgh MC /ID# 138054, Pittsburgh, Pennsylvania, United States
Reading Hospital /ID# 138057, Reading, Pennsylvania, United States
Women and Infants Hospital /ID# 138083, Providence, Rhode Island, United States
Medical University of South Carolina /ID# 138181, Charleston, South Carolina, United States
Sanford Research/USD /ID# 139624, Sioux Falls, South Dakota, United States
Chattanoogas Program in Womens /ID# 139545, Chattanooga, Tennessee, United States
Texas Oncology - Austin Central /ID# 143817, Austin, Texas, United States
Texas Oncology - South Austin /ID# 143818, Austin, Texas, United States
Texas Oncology - Bedford /ID# 143814, Bedford, Texas, United States
Texas Oncology - Medical City Dallas /ID# 143809, Dallas, Texas, United States
Texas Oncology - Medical City Dallas /ID# 143812, Dallas, Texas, United States
Texas Oncology - Forth Worth /ID# 143811, Fort Worth, Texas, United States
Houston Methodist Hospital - Scurlock Tower /ID# 138232, Houston, Texas, United States
Memorial Hermann Hospital /ID# 138238, Houston, Texas, United States
Texas Oncology - The Woodlands /ID# 142003, The Woodlands, Texas, United States
Texas Oncology - Tyler /ID# 143810, Tyler, Texas, United States
University of Utah /ID# 138250, Salt Lake City, Utah, United States
University of Vermont Medical Center /ID# 138251, Burlington, Vermont, United States
University of Virginia /ID# 138088, Charlottesville, Virginia, United States
Carilion Roanoke Memorial Hosp /ID# 139602, Roanoke, Virginia, United States
Skagit Valley Medical Center /ID# 139586, Mount Vernon, Washington, United States
MultiCare Regional Cancer Ctr /ID# 149872, Puyallup, Washington, United States
Multicare Institute for Research and Innovation /ID# 143485, Tacoma, Washington, United States
HSHS St. Vincent Hospital /ID# 139453, Green Bay, Wisconsin, United States
Froedtert & the Medical College of Wisconsin /ID# 139449, Milwaukee, Wisconsin, United States
Coffs Harbour Health Campus /ID# 145132, Coffs Harbour, New South Wales, Australia
Gosford Hospital /ID# 145299, Gosford, New South Wales, Australia
St George Hospital /ID# 145138, Kogarah, New South Wales, Australia
Newcastle Private Hospital /ID# 145834, Lambton Heights, New South Wales, Australia
The Prince of Wales Hospital /ID# 145134, Randwick, New South Wales, Australia
Northern Cancer Institute /ID# 145681, St Leonards, New South Wales, Australia
Calvary Mater Newcastle /ID# 145139, Waratah, New South Wales, Australia
Westmead Hospital /ID# 145137, Westmead, New South Wales, Australia
Southern Medical Day Care Ctr /ID# 145133, Wollongong, New South Wales, Australia
The Townsville Hospital /ID# 149163, Douglas, Queensland, Australia
Royal Brisbane and Women's Hospital /ID# 145135, Herston, Queensland, Australia
Icon Cancer Centre /ID# 148208, South Brisbane, Queensland, Australia
Mater Misericordiae Limited /ID# 145682, South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 150071, Adelaide, South Australia, Australia
Monash Health /ID# 145297, Clayton, Victoria, Australia
Cabrini Health /ID# 145142, Malvern, Victoria, Australia
Royal Womens Hospital /ID# 145136, Parkville, Victoria, Australia
Sir Charles Gairdner Hospital /ID# 145140, Nedlands, Western Australia, Australia
St. John of God Subiaco Hosp /ID# 147742, Subiaco, Western Australia, Australia
Hc Ufmg /Id# 137156, Belo Horizonte, Minas Gerais, Brazil
Hospital Sao Lucas da PUCRS /ID# 137157, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Cancer de Barretos /ID# 137121, Barretos, Sao Paulo, Brazil
Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120, São Paulo, Sao Paulo, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155, Rio de Janeiro, , Brazil
Vejle Sygehus /ID# 137262, Vejle, Syddanmark, Denmark
Regionshospitalet Herning /ID# 137260, Herning, , Denmark
Rambam Health Care Campus /ID# 137434, Haifa, , Israel
The Lady Davis Carmel MC /ID# 137537, Haifa, , Israel
Shaare Zedek Medical Center /ID# 137435, Jerusalem, , Israel
Meir Medical Center /ID# 139397, Kfar Saba, , Israel
Sheba Medical Center /ID# 137436, Ramat Gan, , Israel
Kaplan Medical Center /ID# 137536, Rehovot, , Israel
Aichi Cancer Center Hospital /ID# 148398, Nagoya-shi, Aichi, Japan
National Hospital Organization Kyushu Cancer Center /ID# 149133, Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital /ID# 148697, Kurume-shi, Fukuoka, Japan
Iwate Medical University Hospital /ID# 147721, Shiwa-gun, Iwate, Japan
Kumamoto University Hospital /ID# 154169, Kumamoto-shi, Kumamoto, Japan
Mie University Hospital /ID# 149169, Tsu-shi, Mie, Japan
Tohoku University Hospital /ID# 149818, Sendai-shi, Miyagi, Japan
Niigata University Medical & Dental Hospital /ID# 149488, Niigata-shi, Niigata, Japan
Kindai University Hospital /ID# 154947, Osaka-sayama, Osaka, Japan
Shizuoka Cancer Center /ID# 147723, Sunto-gun, Shizuoka, Japan
The Cancer Institute Hosp JFCR /ID# 148436, Koto-ku, Tokyo, Japan
Keio University Hospital /ID# 148326, Shinjuku-ku, Tokyo, Japan
Yamagata University Hospital /ID# 153646, Yamagata-shi, Yamagata, Japan
Hyogo Cancer Center /ID# 148327, Akashi, , Japan
Kansai Rosai Hospital /ID# 149237, Amagasaki, , Japan
The Jikei Univ. Kashiwa Hosp. /ID# 149238, Kashiwa-shi, , Japan
St. Marianna Univ Hospital /ID# 149327, Kawasaki, , Japan
NHO Kure Medical Center and Ch /ID# 148569, Kure, , Japan
Shikoku Cancer Center /ID# 148382, Matsuyama, , Japan
Osaka International Cancer Institute /ID# 150778, Osaka, , Japan
Hokkaido Cancer Center /ID# 148570, Sapporo, , Japan
The Jikei University Hospital /ID# 148691, Tokyo, , Japan
National Cancer Center /ID# 139404, Goyang, Gyeonggido, Korea, Republic of
Korea University Anam Hospital /ID# 136908, 성북구, Gyeonggido, Korea, Republic of
Gangnam Severance Hospital /ID# 136835, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center /ID# 136834, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital /ID# 136909, Seoul, , Korea, Republic of
Asan Medical Center /ID# 136836, Seoul, , Korea, Republic of
Auckland City Hospital /ID# 145123, Auckland, , New Zealand
Uniwersyteckie C. Kliniczne /ID# 138021, Gdańsk, , Poland
Hospital Duran i Reynals /ID# 137298, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Univ Vall d'Hebron /ID# 137297, Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 137300, Barcelona, , Spain
Hospital Clin Univ San Carlos /ID# 137402, Madrid, , Spain
Hosp Univ 12 de Octubre /ID# 137299, Madrid, , Spain
Hosp Univ Madrid Sanchinarro /ID# 137414, Madrid, , Spain
Fundacion Inst Valenciano Onc /ID# 137403, Valencia, , Spain
Norfolk and Norwich Univ Hosp /ID# 137969, Norwich, Norfolk, United Kingdom
Beatson west of scotland cancer center /ID# 137965, Glasgow, Scotland, United Kingdom
Ninewells Hospital /ID# 137967, Dundee, , United Kingdom
James Paget University Hosp /ID# 137970, Great Yarmouth, , United Kingdom
Imanova Limited, Hammersmith Hospital /ID# 137966, London, , United Kingdom
Oxford Univ Hosp NHS Trust /ID# 137973, Oxford, , United Kingdom
Name: AbbVie Inc.
Affiliation: AbbVie
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