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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: AbbVie Inc.

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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