AzTrials
AzTrials

Ovarian CancerPhase 3VELIANCT02470585

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

A Phase 3 study testing Veliparib, Paclitaxel and Carboplatin in people with Ovarian Cancer and Ovarian Neoplasm, run by AbbVie at 210 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer, Ovarian Neoplasm
What is being tested?
Veliparib, Paclitaxel and Carboplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,140 participants
Where
210 sitesin 11 countries
Study dates
14 Jul 2015to 5 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

210 sites in 11 countries.

210 sites in 11 countries

United States135 sites

  • Abington Memorial Hospital /ID# 138086

    Abington, Pennsylvania, 19001

  • Women's Cancer Care Associates /ID# 138234

    Albany, New York, 12208

  • University of New Mexico /ID# 144220

    Albuquerque, New Mexico, 87102

  • SW Gynecologic Oncology Assoc /ID# 147097

    Albuquerque, New Mexico, 87106

  • McFarland Clinic, PC /ID# 139455

    Ames, Iowa, 50010

  • Alaska Womens Cancer Care /ID# 138231

    Anchorage, Alaska, 99508-4684

  • Hope Womens Cancer Centers /ID# 139614

    Asheville, North Carolina, 28816

  • Georgia Regents University /ID# 138085

    Augusta, Georgia, 30912

  • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499

    Aurora, Colorado, 80014

  • Univ of Colorado Cancer Center /ID# 138016

    Aurora, Colorado, 80045

  • Texas Oncology - Austin Central /ID# 143817

    Austin, Texas, 78731

  • Texas Oncology - South Austin /ID# 143818

    Austin, Texas, 78745

  • Greater Baltimore Medical Ctr /ID# 138049

    Baltimore, Maryland, 21204

  • Sinai Hospital of Baltimore /ID# 141306

    Baltimore, Maryland, 21215

  • Texas Oncology - Bedford /ID# 143814

    Bedford, Texas, 76022

  • University of Alabama at Birmingham - Main /ID# 138087

    Birmingham, Alabama, 35233

  • SUNY Downstate Medical Center /ID# 139533

    Brooklyn, New York, 11203

  • Roswell Park Comprehensive Cancer Center /ID# 138052

    Buffalo, New York, 14263

  • University of Vermont Medical Center /ID# 138251

    Burlington, Vermont, 05401-1473

  • MD Anderson Cancer Ctr at Coop /ID# 139616

    Camden, New Jersey, 08103

  • Univ NC Chapel Hill /ID# 138547

    Chapel Hill, North Carolina, 27514-4220

  • Medical University of South Carolina /ID# 138181

    Charleston, South Carolina, 29425

  • Atrium Health Carolinas Medical Center /ID# 139568

    Charlotte, North Carolina, 28203

  • Presbyterian Cancer Center /ID# 139590

    Charlotte, North Carolina, 28204

  • University of Virginia /ID# 138088

    Charlottesville, Virginia, 22908

  • Chattanoogas Program in Womens /ID# 139545

    Chattanooga, Tennessee, 37403

  • Rush University Medical Center /ID# 143491

    Chicago, Illinois, 60612

  • University of Chicago /ID# 139612

    Chicago, Illinois, 60637-1443

  • University of Cincinnati /ID# 139619

    Cincinnati, Ohio, 45267-0585

  • Univ Hosp Cleveland /ID# 139615

    Cleveland, Ohio, 44106

  • Fairview Hospital /ID# 144403

    Cleveland, Ohio, 44111

  • Cleveland Clinic Main Campus /ID# 139501

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center /ID# 139571

    Columbia, Missouri, 65212-1000

  • IACT Health /ID# 138058

    Columbus, Georgia, 31904-8946

  • The Ohio State University - Columbus /ID# 138053

    Columbus, Ohio, 43210

  • Columbus NCORP /ID# 139587

    Columbus, Ohio, 43215

  • John Muir Medical Center /ID# 139618

    Concord, California, 94520

  • Texas Oncology - Medical City Dallas /ID# 143809

    Dallas, Texas, 75230

  • Texas Oncology - Medical City Dallas /ID# 143812

    Dallas, Texas, 75230

  • Wayne State University /ID# 139601

    Detroit, Michigan, 48201-2013

  • Henry Ford Health System /ID# 139536

    Detroit, Michigan, 48202

  • Duke University Medical Center /ID# 138048

    Durham, North Carolina, 27710-3000

  • Willamette Valley Cancer Institute /ID# 140318

    Eugene, Oregon, 97401-6043

  • NorthShore University HealthSystem - Evanston Hospital /ID# 139451

    Evanston, Illinois, 60201

  • Texas Oncology - Forth Worth /ID# 143811

    Fort Worth, Texas, 76104-2150

  • HSHS St. Vincent Hospital /ID# 139453

    Green Bay, Wisconsin, 54301

  • Hackensack Univ Med Ctr /ID# 143776

    Hackensack, New Jersey, 07601

  • Sharma, Hinsdale, IL /ID# 140326

    Hinsdale, Illinois, 60521

  • The Queens Medical Center /ID# 141709

    Honolulu, Hawaii, 96813

  • Kapiolani Medical Center /ID# 140319

    Honolulu, Hawaii, 96826

  • Houston Methodist Hospital - Scurlock Tower /ID# 138232

    Houston, Texas, 77030

  • Memorial Hermann Hospital /ID# 138238

    Houston, Texas, 77030

  • Tennessee Valley Gyn-Onc /ID# 139548

    Huntsville, Alabama, 35805

  • Indiana Univ School Medicine /ID# 139610

    Indianapolis, Indiana, 46202

  • Saint Vincent /ID# 139537

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics /ID# 138082

    Iowa City, Iowa, 52242

  • St. Dominic Hospital /ID# 138241

    Jackson, Mississippi, 39216

  • Univ Kansas Med Ctr /ID# 140322

    Kansas City, Kansas, 66160

  • Womens Cancer Center /ID# 138062

    Kettering, Ohio, 45429-1226

  • Ucsd /Id# 140323

    La Jolla, California, 92093

  • Northwell Health /ID# 139572

    Lake Success, New York, 11042

  • Womens Cancer Center of Nevada /ID# 138092

    Las Vegas, Nevada, 89169

  • Dartmouth-Hitchcock Medical Center /ID# 139502

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington /ID# 139542

    Lexington, Kentucky, 40503

  • University of Kentucky Chandler Medical Center /ID# 138060

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences /ID# 138253

    Little Rock, Arkansas, 72205

  • Long Beach Memorial Medical Ct /ID# 147526

    Long Beach, California, 90806

  • Kaiser Permanente /ID# 141305

    Los Angeles, California, 90027

  • University of California, Los Angeles /ID# 138179

    Los Angeles, California, 90095

  • Norton Cancer Institute /ID# 139567

    Louisville, Kentucky, 40202-3700

  • Hillcrest Hospital /ID# 144404

    Mayfield Heights, Ohio, 44124

  • University of Miami /ID# 139457

    Miami, Florida, 33136

  • Froedtert & the Medical College of Wisconsin /ID# 139449

    Milwaukee, Wisconsin, 53226-3522

  • University of South Alabama /ID# 138091

    Mobile, Alabama, 36604-3302

  • Skagit Valley Medical Center /ID# 139586

    Mount Vernon, Washington, 98273

  • Hartford Healthcare /ID# 138184

    New Britain, Connecticut, 6053

  • Yale University /ID# 138056

    New Haven, Connecticut, 06510

  • Icahn School of Med Mt. Sinai /ID# 139617

    New York, New York, 10029

  • Columbia University Medical Center /ID# 138252

    New York, New York, 10032-3729

  • Memorial Sloan Kettering Cancer Center /ID# 138017

    New York, New York, 10065-6007

  • Memorial Sloan Kettering Cancer Center /ID# 154464

    New York, New York, 10065-6007

  • Univ Oklahoma HSC /ID# 138020

    Oklahoma City, Oklahoma, 73104

  • Nebraska Methodist Hospital /ID# 139600

    Omaha, Nebraska, 68114

  • Medical Oncology Care Assoc /ID# 139498

    Orange, California, 92868-4304

  • Univ CA, Irvine Med Ctr /ID# 139613

    Orange, California, 92868

  • Advocate Lutheran General Hosp /ID# 139489

    Park Ridge, Illinois, 60068

  • University of Pennsylvania /ID# 140079

    Philadelphia, Pennsylvania, 19104-5502

  • Thomas Jefferson University /ID# 138239

    Philadelphia, Pennsylvania, 19107-4414

  • Fox Chase Cancer Center /ID# 149479

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh MC /ID# 138054

    Pittsburgh, Pennsylvania, 15260

  • MMP Women's Health /ID# 139544

    Portland, Maine, 04102

  • Kaiser Permanente, NW /ID# 138249

    Portland, Oregon, 97227

  • Women and Infants Hospital /ID# 138083

    Providence, Rhode Island, 02905

  • MultiCare Regional Cancer Ctr /ID# 149872

    Puyallup, Washington, 93872

  • Reading Hospital /ID# 138057

    Reading, Pennsylvania, 19611

  • Renown Regional Medical Center /ID# 138237

    Reno, Nevada, 89502

  • Carilion Roanoke Memorial Hosp /ID# 139602

    Roanoke, Virginia, 24014

  • Mayo Clinic - Rochester /ID# 139565

    Rochester, Minnesota, 55905-0001

  • Weinberg Cancer Inst Franklin /ID# 138235

    Rossville, Maryland, 21237

  • William Beaumont Hospital /ID# 139550

    Royal Oak, Michigan, 48073-6710

  • UC Davis Comprehensive Cancer Center - Main /ID# 144439

    Sacramento, California, 95817

  • Mmcorc /Id# 139534

    Saint Louis Park, Minnesota, 55416

  • University of Utah /ID# 138250

    Salt Lake City, Utah, 84112-5500

  • California Pacific Medical Ctr /ID# 138177

    San Francisco, California, 94115

  • Kaiser Permanente - San Francisco /ID# 142051

    San Francisco, California, 94115

  • Univ California, San Francisco /ID# 138178

    San Francisco, California, 94143-2204

  • Kaiser Permanente-Santa Clara /ID# 142053

    Santa Clara, California, 95051-5173

  • Sarasota Memorial Health Care /ID# 138180

    Sarasota, Florida, 34239

  • Memorial Health Univ Med Ctr /ID# 138019

    Savannah, Georgia, 31404

  • St. Joseph's/Candler /ID# 138090

    Savannah, Georgia, 31405

  • Sanford Research/USD /ID# 139624

    Sioux Falls, South Dakota, 57104-8805

  • Baystate Medical Center /ID# 139456

    Springfield, Massachusetts, 01199

  • Cancer Research For the Ozarks /ID# 139538

    Springfield, Missouri, 65804

  • Ferrell-Duncan Clinic /ID# 143484

    Springfield, Missouri, 65807

  • Washington University-School of Medicine /ID# 138089

    St Louis, Missouri, 63110

  • Women's Cancer Associates /ID# 140321

    St. Petersburg, Florida, 33701

  • Stanford University School of Med /ID# 139450

    Stanford, California, 94305-2200

  • Palo Alto Medical Foundation /ID# 139452

    Sunnyvale, California, 94086

  • SUNY Upstate Medical University - Downtown /ID# 139513

    Syracuse, New York, 13210

  • Multicare Institute for Research and Innovation /ID# 143485

    Tacoma, Washington, 98405

  • Moffitt Cancer Center /ID# 138061

    Tampa, Florida, 33612-9416

  • Montefiore Medical Center /ID# 139585

    The Bronx, New York, 10461

  • Texas Oncology - The Woodlands /ID# 142003

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, PC-HOPE /ID# 142002

    Tucson, Arizona, 85711-2701

  • Arizona Oncology Associates, PC-HOPE /ID# 143805

    Tucson, Arizona, 85711-2701

  • Arizona Oncology Associates, PC-HOPE /ID# 143806

    Tucson, Arizona, 85711-2701

  • Arizona Oncology Associates, PC-HOPE /ID# 143808

    Tucson, Arizona, 85711-2701

  • University of Arizona Cancer Center - North Campus /ID# 138084

    Tucson, Arizona, 85719-1478

  • University of Arizona Cancer Center - North Campus /ID# 139495

    Tucson, Arizona, 85719-1478

  • Oklahoma Cancer Specialists /ID# 138059

    Tulsa, Oklahoma, 74146

  • Texas Oncology - Tyler /ID# 143810

    Tyler, Texas, 75702

  • Kaiser Permanente Medical Ctr-Vallejo /ID# 139492

    Vallejo, California, 94589-2441

  • Kaiser Permanente- Walnut Creek /ID# 142052

    Walnut Creek, California, 94596

  • Wake Forest Baptist Medical Center /ID# 139588

    Winston-Salem, North Carolina, 27157-0001

  • UMass Memorial Medical Center /ID# 139458

    Worcester, Massachusetts, 01655

Other trials in United States

Japan22 sites

  • Hyogo Cancer Center /ID# 148327

    Akashi, 673-8558

  • Kansai Rosai Hospital /ID# 149237

    Amagasaki, 660-8511

  • National Hospital Organization Kyushu Cancer Center /ID# 149133

    Fukuoka, Fukuoka, 811-1395

  • The Jikei Univ. Kashiwa Hosp. /ID# 149238

    Kashiwa-shi, 277-0004

  • St. Marianna Univ Hospital /ID# 149327

    Kawasaki, 216-8511

  • The Cancer Institute Hosp JFCR /ID# 148436

    Koto-ku, Tokyo, 135-8550

  • Kumamoto University Hospital /ID# 154169

    Kumamoto, Kumamoto, 860-8556

  • NHO Kure Medical Center and Ch /ID# 148569

    Kure, 737-0023

  • Kurume University Hospital /ID# 148697

    Kurume-shi, Fukuoka, 830-0011

  • Shikoku Cancer Center /ID# 148382

    Matsuyama, 791-0280

  • Aichi Cancer Center Hospital /ID# 148398

    Nagoya, Aichi-ken, 464-8681

  • Niigata University Medical & Dental Hospital /ID# 149488

    Niigata, Niigata, 951-8520

  • Osaka International Cancer Institute /ID# 150778

    Osaka, 541-8567

  • Kindai University Hospital /ID# 154947

    Ōsaka-sayama, Osaka, 5898511

  • Hokkaido Cancer Center /ID# 148570

    Sapporo, 003-0804

  • Tohoku University Hospital /ID# 149818

    Sendai, Miyagi, 980-8574

  • Keio University Hospital /ID# 148326

    Shinjuku-ku, Tokyo, 160-8582

  • Iwate Medical University Hospital /ID# 147721

    Shiwa-gun, Iwate, 028-3695

  • Shizuoka Cancer Center /ID# 147723

    Sunto-gun, Shizuoka, 411-8777

  • The Jikei University Hospital /ID# 148691

    Tokyo, 105-8461

  • Mie University Hospital /ID# 149169

    Tsu, Mie-ken, 514-8507

  • Yamagata University Hospital /ID# 153646

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Australia19 sites

  • Royal Adelaide Hospital /ID# 150071

    Adelaide, South Australia, 5000

  • Monash Health /ID# 145297

    Clayton, Victoria, 3168

  • Coffs Harbour Health Campus /ID# 145132

    Coffs Harbour, New South Wales, 2450

  • The Townsville Hospital /ID# 149163

    Douglas, Queensland, 4814

  • Gosford Hospital /ID# 145299

    Gosford, New South Wales, 2250

  • Royal Brisbane and Women's Hospital /ID# 145135

    Herston, Queensland, 4029

  • St George Hospital /ID# 145138

    Kogarah, New South Wales, 2217

  • Newcastle Private Hospital /ID# 145834

    Lambton Heights, New South Wales, 2305

  • Cabrini Health /ID# 145142

    Malvern, Victoria, 3144

  • Sir Charles Gairdner Hospital /ID# 145140

    Nedlands, Western Australia, 6009

  • Royal Womens Hospital /ID# 145136

    Parkville, Victoria, 3052

  • The Prince of Wales Hospital /ID# 145134

    Randwick, New South Wales, 2031

  • Icon Cancer Centre /ID# 148208

    South Brisbane, Queensland, 4101

  • Mater Misericordiae Limited /ID# 145682

    South Brisbane, Queensland, 4101

  • Northern Cancer Institute /ID# 145681

    St Leonards, New South Wales, 2065

  • St. John of God Subiaco Hosp /ID# 147742

    Subiaco, Western Australia, 6008

  • Calvary Mater Newcastle /ID# 145139

    Waratah, New South Wales, 2298

  • Westmead Hospital /ID# 145137

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Ctr /ID# 145133

    Wollongong, New South Wales, 2500

Other trials in Australia

Spain7 sites

  • Hospital Univ Vall d'Hebron /ID# 137297

    Barcelona, 08035

  • Hospital Clinic de Barcelona /ID# 137300

    Barcelona, 08036

  • Hospital Duran i Reynals /ID# 137298

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Clin Univ San Carlos /ID# 137402

    Madrid, 28040

  • Hosp Univ 12 de Octubre /ID# 137299

    Madrid, 28041

  • Hosp Univ Madrid Sanchinarro /ID# 137414

    Madrid, 28050

  • Fundacion Inst Valenciano Onc /ID# 137403

    Valencia, 46009

Other trials in Spain

Israel6 sites

  • Rambam Health Care Campus /ID# 137434

    Haifa, 3109601

  • The Lady Davis Carmel MC /ID# 137537

    Haifa, 3436212

  • Shaare Zedek Medical Center /ID# 137435

    Jerusalem, 91031

  • Meir Medical Center /ID# 139397

    Kfar Saba, 4428164

  • Sheba Medical Center /ID# 137436

    Ramat Gan, 5262100

  • Kaplan Medical Center /ID# 137536

    Rehovot, 76100

Other trials in Israel

South Korea6 sites

  • National Cancer Center /ID# 139404

    Goyang, Gyeonggido, 10408

  • Gangnam Severance Hospital /ID# 136835

    Seoul, Seoul Teugbyeolsi, 06273

  • Samsung Medical Center /ID# 136834

    Seoul, Seoul Teugbyeolsi, 06351

  • Seoul National University Hospital /ID# 136909

    Seoul, 03080

  • Asan Medical Center /ID# 136836

    Seoul, 05505

  • Korea University Anam Hospital /ID# 136908

    성북구, Gyeonggido, 02841

Other trials in South Korea

United Kingdom6 sites

  • Ninewells Hospital /ID# 137967

    Dundee, DD1 9SY

  • Beatson west of scotland cancer center /ID# 137965

    Glasgow, Scotland, G12 0YN

  • James Paget University Hosp /ID# 137970

    Great Yarmouth, NR31 6LA

  • Imanova Limited, Hammersmith Hospital /ID# 137966

    London, W12 0HS

  • Norfolk and Norwich Univ Hosp /ID# 137969

    Norwich, Norfolk, NR4 7UY

  • Oxford Univ Hosp NHS Trust /ID# 137973

    Oxford, OX3 7LE

Other trials in United Kingdom

Brazil5 sites

  • Hospital de Cancer de Barretos /ID# 137121

    Barretos, São Paulo, 14784-400

  • Hc Ufmg /Id# 137156

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital Sao Lucas da PUCRS /ID# 137157

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155

    Rio de Janeiro, 20231-050

  • Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120

    São Paulo, São Paulo, 01317-000

Other trials in Brazil

Denmark2 sites

  • Regionshospitalet Herning /ID# 137260

    Herning, 7400

  • Vejle Sygehus /ID# 137262

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

New Zealand1 site

  • Auckland City Hospital /ID# 145123

    Auckland, 1023

Other trials in New Zealand

Poland1 site

  • Uniwersyteckie C. Kliniczne /ID# 138021

    Gdansk, 80-214

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Veliparib, Paclitaxel, Carboplatin, Placebo to Veliparib
Keywords
Veliparib, Carboplatin, Paclitaxel, Overall Survival, ABT-888, Randomized, Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP), Ovarian, BRCA, VELIA
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeliparibDrug

    Also called ABT-888

    Capsules for oral administration

  • PaclitaxelDrug

    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).

  • CarboplatinDrug

    Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.

  • Placebo to VeliparibOther

    Capsules for oral administration

Study groups in NCT02470585
Study groupRoleWhat they receive
Placebo + Carboplatin + Paclitaxel -> PlaceboActive comparatorParticipants 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.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Other: Placebo to Veliparib
Veliparib + Carboplatin + Paclitaxel -> PlaceboExperimentalParticipants 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.
Receives: Drug: Veliparib; Drug: Paclitaxel; Drug: Carboplatin; Other: Placebo to Veliparib
Veliparib + Carboplatin + Paclitaxel -> VeliparibExperimentalParticipants 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.
Receives: Drug: Veliparib; Drug: Paclitaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)

    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.

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

  2. Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)

    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.

    .

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

  3. Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)

    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.

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

Secondary outcomes (9)

  1. Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)

    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.

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

  2. Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)

    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.

    .

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

  3. Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)

    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.

    Measured: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

  4. Overall Survival (OS) in the BRCA-deficient Population

    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.

    Measured: From the time of randomization to the end of the study, up to 98 months

  5. Overall Survival (OS) in the Homologous Recombination Deficiency Population

    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.

    Measured: From the time of randomization to the end of the study, up to 98 months

  6. Overall Survival (OS) in the Whole Population

    OS is defined as the time from the day the participant was randomized to the date of death, and was calculated using Kaplan-Meier methods. 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.

    Measured: From the time of randomization to the end of the study, up to 98 months

  7. 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.

    Measured: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

  8. 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.

    Measured: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

  9. Change From Baseline in Disease Related Symptom (DRS) Score in the Whole 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.

    Measured: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study start14 Jul 2015
  3. Primary completion3 May 2019
  4. Study completion5 Oct 2023

Why it stopped: Business decision not related to patient safety

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02470585
Sponsor's protocol ID
M13-694
Other IDs
2014-005070-11, 2014
Acronym
VELIA
Status last verified
Oct 2024
First submitted
10 Jun 2015
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
Individual data sharing
Yes: 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.

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.

    PubMed 31562800

  • Lafferty J, Secord AA, Bookman M, Coleman RL, Dinh MH, Khandelwal N, Kamalakar R, Cella D. Quality-adjusted progression-free survival analysis of veliparib and carboplatin/paclitaxel compared with chemotherapy alone in patients with newly diagnosed ovarian cancer (VELIA/GOG3005): ancillary analysis of a placebo-controlled, phase 3 randomized trial. Int J Gynecol Cancer. 2026 May;36(5):102819. doi: 10.1016/j.ijgc.2025.102819. Epub 2025 Nov 21.

    PubMed 41565553

  • 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.

    PubMed 34906376

  • 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.

    PubMed 33369580

  • 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.

    PubMed 28665051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Veliparib, Paclitaxel and Carboplatin in people with Ovarian Cancer and Ovarian Neoplasm, run by AbbVie at 210 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in United States, Japan, Australia, Spain, Israel and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1) (time frame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02470585, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.

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