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 (VELIA)

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

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.

Study Overview

• Status: Terminated
• Conditions: Ovarian Cancer; Ovarian Neoplasm
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin; Other: Placebo to Veliparib; Drug: Veliparib

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.

• Study Type: Interventional
• Enrollment (Actual): 1140
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Coffs Harbour Health Campus /ID# 145132
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital /ID# 145299
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital /ID# 145138
    • Lambton Heights, New South Wales, Australia, 2305
      • Newcastle Private Hospital /ID# 145834
    • Randwick, New South Wales, Australia, 2031
      • The Prince of Wales Hospital /ID# 145134
    • St Leonards, New South Wales, Australia, 2065
      • Northern Cancer Institute /ID# 145681
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle /ID# 145139
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 145137
    • Wollongong, New South Wales, Australia, 2500
      • Southern Medical Day Care Ctr /ID# 145133
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • The Townsville Hospital /ID# 149163
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital /ID# 145135
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Centre /ID# 148208
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Limited /ID# 145682
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital /ID# 150071
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health /ID# 145297
    • Malvern, Victoria, Australia, 3144
      • Cabrini Health /ID# 145142
    • Parkville, Victoria, Australia, 3052
      • Royal Womens Hospital /ID# 145136
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital /ID# 145140
    • Subiaco, Western Australia, Australia, 6008
      • St. John of God Subiaco Hosp /ID# 147742
• Brazil
  • Rio de Janeiro, Brazil, 20231-050
    • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Hc Ufmg /Id# 137156
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS /ID# 137157
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784-400
      • Hospital de Cancer de Barretos /ID# 137121
    • São Paulo, Sao Paulo, Brazil, 01317-000
      • Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120
• Denmark
  • Herning, Denmark, 7400
    • Regionshospitalet Herning /ID# 137260
  • Syddanmark
    • Vejle, Syddanmark, Denmark, 7100
      • Vejle Sygehus /ID# 137262
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus /ID# 137434
  • Haifa, Israel, 3436212
    • The Lady Davis Carmel MC /ID# 137537
  • Jerusalem, Israel, 91031
    • Shaare Zedek Medical Center /ID# 137435
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center /ID# 139397
  • Ramat Gan, Israel, 5262100
    • Sheba Medical Center /ID# 137436
  • Rehovot, Israel, 76100
    • Kaplan Medical Center /ID# 137536
• Japan
  • Akashi, Japan, 673-8558
    • Hyogo Cancer Center /ID# 148327
  • Amagasaki, Japan, 660-8511
    • Kansai Rosai Hospital /ID# 149237
  • Kashiwa-shi, Japan, 277-0004
    • The Jikei Univ. Kashiwa Hosp. /ID# 149238
  • Kawasaki, Japan, 216-8511
    • St. Marianna Univ Hospital /ID# 149327
  • Kure, Japan, 737-0023
    • NHO Kure Medical Center and Ch /ID# 148569
  • Matsuyama, Japan, 791-0280
    • Shikoku Cancer Center /ID# 148382
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute /ID# 150778
  • Sapporo, Japan, 003-0804
    • Hokkaido Cancer Center /ID# 148570
  • Tokyo, Japan, 105-8461
    • The Jikei University Hospital /ID# 148691
  • Aichi
    • Nagoya-shi, Aichi, Japan, 464-8681
      • Aichi Cancer Center Hospital /ID# 148398
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 811-1395
      • National Hospital Organization Kyushu Cancer Center /ID# 149133
    • Kurume-shi, Fukuoka, Japan, 830-0011
      • Kurume University Hospital /ID# 148697
  • Iwate
    • Shiwa-gun, Iwate, Japan, 028-3695
      • Iwate Medical University Hospital /ID# 147721
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 860-8556
      • Kumamoto University Hospital /ID# 154169
  • Mie
    • Tsu-shi, Mie, Japan, 514-8507
      • Mie University Hospital /ID# 149169
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-8574
      • Tohoku University Hospital /ID# 149818
  • Niigata
    • Niigata-shi, Niigata, Japan, 951-8520
      • Niigata University Medical & Dental Hospital /ID# 149488
  • Osaka
    • Osaka-sayama, Osaka, Japan, 5898511
      • Kindai University Hospital /ID# 154947
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8777
      • Shizuoka Cancer Center /ID# 147723
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
      • The Cancer Institute Hosp JFCR /ID# 148436
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Keio University Hospital /ID# 148326
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 990-9585
      • Yamagata University Hospital /ID# 153646
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 136909
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center /ID# 136836
  • Gyeonggido
    • Goyang, Gyeonggido, Korea, Republic of, 10408
      • National Cancer Center /ID# 139404
    • 성북구, Gyeonggido, Korea, Republic of, 02841
      • Korea University Anam Hospital /ID# 136908
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06273
      • Gangnam Severance Hospital /ID# 136835
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Samsung Medical Center /ID# 136834
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital /ID# 145123
• Poland
  • Gdańsk, Poland, 80-214
    • Uniwersyteckie C. Kliniczne /ID# 138021
• Spain
  • Barcelona, Spain, 08035
    • Hospital Univ Vall d'Hebron /ID# 137297
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona /ID# 137300
  • Madrid, Spain, 28040
    • Hospital Clin Univ San Carlos /ID# 137402
  • Madrid, Spain, 28041
    • Hosp Univ 12 de Octubre /ID# 137299
  • Madrid, Spain, 28050
    • Hosp Univ Madrid Sanchinarro /ID# 137414
  • Valencia, Spain, 46009
    • Fundacion Inst Valenciano Onc /ID# 137403
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Duran i Reynals /ID# 137298
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Ninewells Hospital /ID# 137967
  • Great Yarmouth, United Kingdom, NR31 6LA
    • James Paget University Hosp /ID# 137970
  • London, United Kingdom, W12 0HS
    • Imanova Limited, Hammersmith Hospital /ID# 137966
  • Oxford, United Kingdom, OX3 7LE
    • Oxford Univ Hosp NHS Trust /ID# 137973
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • Norfolk and Norwich Univ Hosp /ID# 137969
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 0YN
      • Beatson west of scotland cancer center /ID# 137965
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham - Main /ID# 138087
    • Huntsville, Alabama, United States, 35805
      • Tennessee Valley Gyn-Onc /ID# 139548
    • Mobile, Alabama, United States, 36604-3302
      • University of South Alabama /ID# 138091
  • Alaska
    • Anchorage, Alaska, United States, 99508-4684
      • Alaska Womens Cancer Care /ID# 138231
  • Arizona
    • Tucson, Arizona, United States, 85711-2701
      • Arizona Oncology Associates, PC-HOPE /ID# 142002
    • Tucson, Arizona, United States, 85711-2701
      • Arizona Oncology Associates, PC-HOPE /ID# 143805
    • Tucson, Arizona, United States, 85711-2701
      • Arizona Oncology Associates, PC-HOPE /ID# 143806
    • Tucson, Arizona, United States, 85711-2701
      • Arizona Oncology Associates, PC-HOPE /ID# 143808
    • Tucson, Arizona, United States, 85719-1478
      • University of Arizona Cancer Center - North Campus /ID# 138084
    • Tucson, Arizona, United States, 85719-1478
      • University of Arizona Cancer Center - North Campus /ID# 139495
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences /ID# 138253
  • California
    • Concord, California, United States, 94520
      • John Muir Medical Center /ID# 139618
    • La Jolla, California, United States, 92093
      • Ucsd /Id# 140323
    • Long Beach, California, United States, 90806
      • Long Beach Memorial Medical Ct /ID# 147526
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente /ID# 141305
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles /ID# 138179
    • Orange, California, United States, 92868-4304
      • Medical Oncology Care Assoc /ID# 139498
    • Orange, California, United States, 92868
      • Univ CA, Irvine Med Ctr /ID# 139613
    • Sacramento, California, United States, 95817
      • UC Davis Comprehensive Cancer Center - Main /ID# 144439
    • San Francisco, California, United States, 94115
      • California Pacific Medical Ctr /ID# 138177
    • San Francisco, California, United States, 94115
      • Kaiser Permanente - San Francisco /ID# 142051
    • San Francisco, California, United States, 94143-2204
      • Univ California, San Francisco /ID# 138178
    • Santa Clara, California, United States, 95051-5173
      • Kaiser Permanente-Santa Clara /ID# 142053
    • Stanford, California, United States, 94305-2200
      • Stanford University School of Med /ID# 139450
    • Sunnyvale, California, United States, 94086
      • Palo Alto Medical Foundation /ID# 139452
    • Vallejo, California, United States, 94589-2441
      • Kaiser Permanente Medical Ctr-Vallejo /ID# 139492
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente- Walnut Creek /ID# 142052
  • Colorado
    • Aurora, Colorado, United States, 80014
      • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado Cancer Center /ID# 138016
  • Connecticut
    • New Britain, Connecticut, United States, 6053
      • Hartford Healthcare /ID# 138184
    • New Haven, Connecticut, United States, 06510
      • Yale University /ID# 138056
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami /ID# 139457
    • Saint Petersburg, Florida, United States, 33701
      • Women's Cancer Associates /ID# 140321
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Health Care /ID# 138180
    • Tampa, Florida, United States, 33612-9416
      • Moffitt Cancer Center /ID# 138061
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University /ID# 138085
    • Columbus, Georgia, United States, 31904-8946
      • IACT Health /ID# 138058
    • Savannah, Georgia, United States, 31404
      • Memorial Health Univ Med Ctr /ID# 138019
    • Savannah, Georgia, United States, 31405
      • St. Joseph's/Candler /ID# 138090
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • The Queens Medical Center /ID# 141709
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center /ID# 140319
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center /ID# 143491
    • Chicago, Illinois, United States, 60637-1443
      • University of Chicago /ID# 139612
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem - Evanston Hospital /ID# 139451
    • Hinsdale, Illinois, United States, 60521
      • Sharma, Hinsdale, IL /ID# 140326
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hosp /ID# 139489
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ School Medicine /ID# 139610
    • Indianapolis, Indiana, United States, 46260
      • Saint Vincent /ID# 139537
  • Iowa
    • Ames, Iowa, United States, 50010
      • McFarland Clinic, PC /ID# 139455
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics /ID# 138082
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Univ Kansas Med Ctr /ID# 140322
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington /ID# 139542
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center /ID# 138060
    • Louisville, Kentucky, United States, 40202-3700
      • Norton Cancer Institute /ID# 139567
  • Maine
    • Portland, Maine, United States, 04102
      • MMP Women's Health /ID# 139544
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Ctr /ID# 138049
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore /ID# 141306
    • Rossville, Maryland, United States, 21237
      • Weinberg Cancer Inst Franklin /ID# 138235
  • Massachusetts
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center /ID# 139456
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center /ID# 139458
  • Michigan
    • Detroit, Michigan, United States, 48201-2013
      • Wayne State University /ID# 139601
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 139536
    • Royal Oak, Michigan, United States, 48073-6710
      • William Beaumont Hospital /ID# 139550
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 139565
    • Saint Louis Park, Minnesota, United States, 55416
      • Mmcorc /Id# 139534
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • St. Dominic Hospital /ID# 138241
  • Missouri
    • Columbia, Missouri, United States, 65212-1000
      • Ellis Fischel Cancer Center /ID# 139571
    • Saint Louis, Missouri, United States, 63110
      • Washington University-School of Medicine /ID# 138089
    • Springfield, Missouri, United States, 65804
      • Cancer Research For the Ozarks /ID# 139538
    • Springfield, Missouri, United States, 65807
      • Ferrell-Duncan Clinic /ID# 143484
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Nebraska Methodist Hospital /ID# 139600
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Womens Cancer Center of Nevada /ID# 138092
    • Reno, Nevada, United States, 89502
      • Renown Regional Medical Center /ID# 138237
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center /ID# 139502
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • MD Anderson Cancer Ctr at Coop /ID# 139616
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Univ Med Ctr /ID# 143776
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico /ID# 144220
    • Albuquerque, New Mexico, United States, 87106
      • SW Gynecologic Oncology Assoc /ID# 147097
  • New York
    • Albany, New York, United States, 12208
      • Women's Cancer Care Associates /ID# 138234
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center /ID# 139585
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center /ID# 139533
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center /ID# 138052
    • Lake Success, New York, United States, 11042
      • Northwell Health /ID# 139572
    • New York, New York, United States, 10029
      • Icahn School of Med Mt. Sinai /ID# 139617
    • New York, New York, United States, 10032-3729
      • Columbia University Medical Center /ID# 138252
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center /ID# 138017
    • New York, New York, United States, 10065-6007
      • Memorial Sloan Kettering Cancer Center /ID# 154464
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University - Downtown /ID# 139513
  • North Carolina
    • Asheville, North Carolina, United States, 28816
      • Hope Womens Cancer Centers /ID# 139614
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 138547
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Carolinas Medical Center /ID# 139568
    • Charlotte, North Carolina, United States, 28204
      • Presbyterian Cancer Center /ID# 139590
    • Durham, North Carolina, United States, 27710-3000
      • Duke University Medical Center /ID# 138048
    • Winston-Salem, North Carolina, United States, 27157-0001
      • Wake Forest Baptist Medical Center /ID# 139588
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0585
      • University of Cincinnati /ID# 139619
    • Cleveland, Ohio, United States, 44106
      • Univ Hosp Cleveland /ID# 139615
    • Cleveland, Ohio, United States, 44111
      • Fairview Hospital /ID# 144403
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus /ID# 139501
    • Columbus, Ohio, United States, 43210
      • The Ohio State University - Columbus /ID# 138053
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP /ID# 139587
    • Kettering, Ohio, United States, 45429-1226
      • Womens Cancer Center /ID# 138062
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital /ID# 144404
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Univ Oklahoma HSC /ID# 138020
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists /ID# 138059
  • Oregon
    • Eugene, Oregon, United States, 97401-6043
      • Willamette Valley Cancer Institute /ID# 140318
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente, NW /ID# 138249
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Memorial Hospital /ID# 138086
    • Philadelphia, Pennsylvania, United States, 19104-5502
      • University of Pennsylvania /ID# 140079
    • Philadelphia, Pennsylvania, United States, 19107-4414
      • Thomas Jefferson University /ID# 138239
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center /ID# 149479
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh MC /ID# 138054
    • Reading, Pennsylvania, United States, 19611
      • Reading Hospital /ID# 138057
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital /ID# 138083
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina /ID# 138181
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104-8805
      • Sanford Research/USD /ID# 139624
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Chattanoogas Program in Womens /ID# 139545
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Oncology - Austin Central /ID# 143817
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin /ID# 143818
    • Bedford, Texas, United States, 76022
      • Texas Oncology - Bedford /ID# 143814
    • Dallas, Texas, United States, 75230
      • Texas Oncology - Medical City Dallas /ID# 143809
    • Dallas, Texas, United States, 75230
      • Texas Oncology - Medical City Dallas /ID# 143812
    • Fort Worth, Texas, United States, 76104-2150
      • Texas Oncology - Forth Worth /ID# 143811
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital - Scurlock Tower /ID# 138232
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital /ID# 138238
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - The Woodlands /ID# 142003
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler /ID# 143810
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • University of Utah /ID# 138250
  • Vermont
    • Burlington, Vermont, United States, 05401-1473
      • University of Vermont Medical Center /ID# 138251
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia /ID# 138088
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hosp /ID# 139602
  • Washington
    • Mount Vernon, Washington, United States, 98273
      • Skagit Valley Medical Center /ID# 139586
    • Puyallup, Washington, United States, 93872
      • MultiCare Regional Cancer Ctr /ID# 149872
    • Tacoma, Washington, United States, 98405
      • Multicare Institute for Research and Innovation /ID# 143485
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • HSHS St. Vincent Hospital /ID# 139453
    • Milwaukee, Wisconsin, United States, 53226-3522
      • Froedtert & the Medical College of Wisconsin /ID# 139449

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. 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.
8. Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
9. 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:

1. 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.
2. 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.
3. 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.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. 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.
8. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Placebo + Carboplatin + Paclitaxel -> Placebo; Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.	Drug: Paclitaxel; Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).; Drug: Carboplatin; Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.; Other: Placebo to Veliparib; Capsules for oral administration
Experimental: Veliparib + Carboplatin + Paclitaxel -> Placebo; Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.	Drug: Paclitaxel; Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).; Drug: Carboplatin; Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.; Other: Placebo to Veliparib; Capsules for oral administration; Drug: Veliparib; Capsules for oral administration; Other Names: ABT-888
Experimental: Veliparib + Carboplatin + Paclitaxel -> Veliparib; Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles.	Drug: Paclitaxel; Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).; Drug: Carboplatin; Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.; Drug: Veliparib; Capsules for oral administration; Other Names: ABT-888

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) in the BRCA-deficient Population	PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort	PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. .	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Progression-Free Survival (PFS) in the Intention-to-treat Population	PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.	From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the day the participant was randomized to the date of death. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT and HRD populations.	Approximately 8 years from randomization.
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population	The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.	Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population	The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.	Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population	The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.	Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

General Publications

• Coleman RL, Fleming GF, Brady MF, Swisher EM, Steffensen KD, Friedlander M, Okamoto A, Moore KN, Efrat Ben-Baruch N, Werner TL, Cloven NG, Oaknin A, DiSilvestro PA, Morgan MA, Nam JH, Leath CA 3rd, Nicum S, Hagemann AR, Littell RD, Cella D, Baron-Hay S, Garcia-Donas J, Mizuno M, Bell-McGuinn K, Sullivan DM, Bach BA, Bhattacharya S, Ratajczak CK, Ansell PJ, Dinh MH, Aghajanian C, Bookman MA. Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2403-2415. doi: 10.1056/NEJMoa1909707. Epub 2019 Sep 28.
• Swisher EM, Aghajanian C, O'Malley DM, Fleming GF, Kaufmann SH, Levine DA, Birrer MJ, Moore KN, Spirtos NM, Shahin MS, Reid TJ, Friedlander M, Steffensen KD, Okamoto A, Sehgal V, Ansell PJ, Dinh MH, Bookman MA, Coleman RL. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecol Oncol. 2022 Feb;164(2):245-253. doi: 10.1016/j.ygyno.2021.12.003. Epub 2021 Dec 11.
• Washington CR, Moore KN. PARP inhibitors in the treatment of ovarian cancer: a review. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):1-6. doi: 10.1097/GCO.0000000000000675.
• Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2015
• Primary Completion (Actual): May 3, 2019
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 10, 2015
• First Posted (Estimated): June 12, 2015

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ABT-888; Randomized; Carboplatin; Paclitaxel; Overall Survival; Ovarian; BRCA; Veliparib; Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP); VELIA
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Poly(ADP-ribose) Polymerase Inhibitors; Carboplatin; Paclitaxel; Veliparib
• Other Study ID Numbers: M13-694; 2014-005070-11 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• product manufactured in and exported from the U.S.: No