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

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,140

Participants

Timeline

Start Date

July 14, 2015

Primary Completion Date

May 3, 2019

Study Completion Date

October 5, 2023

Conditions
Ovarian CancerOvarian Neoplasm
Interventions
DRUG

Veliparib

Capsules for oral administration

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

Trial Locations (210)

1023

Auckland City Hospital /ID# 145123, Auckland

2031

The Prince of Wales Hospital /ID# 145134, Randwick

2065

Northern Cancer Institute /ID# 145681, St Leonards

2145

Westmead Hospital /ID# 145137, Westmead

2217

St George Hospital /ID# 145138, Kogarah

2250

Gosford Hospital /ID# 145299, Gosford

2298

Calvary Mater Newcastle /ID# 145139, Waratah

2305

Newcastle Private Hospital /ID# 145834, Lambton Heights

2450

Coffs Harbour Health Campus /ID# 145132, Coffs Harbour

2500

Southern Medical Day Care Ctr /ID# 145133, Wollongong

3052

Royal Womens Hospital /ID# 145136, Parkville

3144

Cabrini Health /ID# 145142, Malvern

3168

Monash Health /ID# 145297, Clayton

4029

Royal Brisbane and Women's Hospital /ID# 145135, Herston

4101

Icon Cancer Centre /ID# 148208, South Brisbane

Mater Misericordiae Limited /ID# 145682, South Brisbane

4814

The Townsville Hospital /ID# 149163, Douglas

5000

Royal Adelaide Hospital /ID# 150071, Adelaide

6008

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

6009

Sir Charles Gairdner Hospital /ID# 145140, Nedlands

6053

Hartford Healthcare /ID# 138184, New Britain

7100

Vejle Sygehus /ID# 137262, Vejle

7400

Regionshospitalet Herning /ID# 137260, Herning

10029

Icahn School of Med Mt. Sinai /ID# 139617, New York

10408

National Cancer Center /ID# 139404, Goyang

10461

Montefiore Medical Center /ID# 139585, The Bronx

11042

Northwell Health /ID# 139572, Lake Success

11203

SUNY Downstate Medical Center /ID# 139533, Brooklyn

12208

Women's Cancer Care Associates /ID# 138234, Albany

13210

SUNY Upstate Medical University - Downtown /ID# 139513, Syracuse

14263

Roswell Park Comprehensive Cancer Center /ID# 138052, Buffalo

15260

University of Pittsburgh MC /ID# 138054, Pittsburgh

19001

Abington Memorial Hospital /ID# 138086, Abington

19111

Fox Chase Cancer Center /ID# 149479, Philadelphia

19611

Reading Hospital /ID# 138057, Reading

21204

Greater Baltimore Medical Ctr /ID# 138049, Baltimore

21215

Sinai Hospital of Baltimore /ID# 141306, Baltimore

21237

Weinberg Cancer Inst Franklin /ID# 138235, Rossville

22908

University of Virginia /ID# 138088, Charlottesville

24014

Carilion Roanoke Memorial Hosp /ID# 139602, Roanoke

28040

Hospital Clin Univ San Carlos /ID# 137402, Madrid

28041

Hosp Univ 12 de Octubre /ID# 137299, Madrid

28050

Hosp Univ Madrid Sanchinarro /ID# 137414, Madrid

28203

Atrium Health Carolinas Medical Center /ID# 139568, Charlotte

28204

Presbyterian Cancer Center /ID# 139590, Charlotte

28816

Hope Womens Cancer Centers /ID# 139614, Asheville

29425

Medical University of South Carolina /ID# 138181, Charleston

30912

Georgia Regents University /ID# 138085, Augusta

31404

Memorial Health Univ Med Ctr /ID# 138019, Savannah

31405

St. Joseph's/Candler /ID# 138090, Savannah

33136

University of Miami /ID# 139457, Miami

33701

Women's Cancer Associates /ID# 140321, St. Petersburg

34239

Sarasota Memorial Health Care /ID# 138180, Sarasota

35233

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

35805

Tennessee Valley Gyn-Onc /ID# 139548, Huntsville

37403

Chattanoogas Program in Womens /ID# 139545, Chattanooga

39216

St. Dominic Hospital /ID# 138241, Jackson

40503

Baptist Health Lexington /ID# 139542, Lexington

40536

University of Kentucky Chandler Medical Center /ID# 138060, Lexington

43210

The Ohio State University - Columbus /ID# 138053, Columbus

43215

Columbus NCORP /ID# 139587, Columbus

44106

Univ Hosp Cleveland /ID# 139615, Cleveland

44111

Fairview Hospital /ID# 144403, Cleveland

44124

Hillcrest Hospital /ID# 144404, Mayfield Heights

44195

Cleveland Clinic Main Campus /ID# 139501, Cleveland

46009

Fundacion Inst Valenciano Onc /ID# 137403, Valencia

46202

Indiana Univ School Medicine /ID# 139610, Indianapolis

46260

Saint Vincent /ID# 139537, Indianapolis

48202

Henry Ford Health System /ID# 139536, Detroit

50010

McFarland Clinic, PC /ID# 139455, Ames

52242

University of Iowa Hospitals and Clinics /ID# 138082, Iowa City

54301

HSHS St. Vincent Hospital /ID# 139453, Green Bay

55416

Mmcorc /Id# 139534, Saint Louis Park

60068

Advocate Lutheran General Hosp /ID# 139489, Park Ridge

60201

NorthShore University HealthSystem - Evanston Hospital /ID# 139451, Evanston

60521

Sharma, Hinsdale, IL /ID# 140326, Hinsdale

60612

Rush University Medical Center /ID# 143491, Chicago

63110

Washington University-School of Medicine /ID# 138089, St Louis

65804

Cancer Research For the Ozarks /ID# 139538, Springfield

65807

Ferrell-Duncan Clinic /ID# 143484, Springfield

66160

Univ Kansas Med Ctr /ID# 140322, Kansas City

68114

Nebraska Methodist Hospital /ID# 139600, Omaha

72205

University of Arkansas for Medical Sciences /ID# 138253, Little Rock

73104

Univ Oklahoma HSC /ID# 138020, Oklahoma City

74146

Oklahoma Cancer Specialists /ID# 138059, Tulsa

75230

Texas Oncology - Medical City Dallas /ID# 143809, Dallas

Texas Oncology - Medical City Dallas /ID# 143812, Dallas

75702

Texas Oncology - Tyler /ID# 143810, Tyler

76022

Texas Oncology - Bedford /ID# 143814, Bedford

76100

Kaplan Medical Center /ID# 137536, Rehovot

77030

Houston Methodist Hospital - Scurlock Tower /ID# 138232, Houston

Memorial Hermann Hospital /ID# 138238, Houston

77380

Texas Oncology - The Woodlands /ID# 142003, The Woodlands

78731

Texas Oncology - Austin Central /ID# 143817, Austin

78745

Texas Oncology - South Austin /ID# 143818, Austin

80014

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

80045

Univ of Colorado Cancer Center /ID# 138016, Aurora

87102

University of New Mexico /ID# 144220, Albuquerque

87106

SW Gynecologic Oncology Assoc /ID# 147097, Albuquerque

89169

Womens Cancer Center of Nevada /ID# 138092, Las Vegas

89502

Renown Regional Medical Center /ID# 138237, Reno

90027

Kaiser Permanente /ID# 141305, Los Angeles

90095

University of California, Los Angeles /ID# 138179, Los Angeles

90806

Long Beach Memorial Medical Ct /ID# 147526, Long Beach

91031

Shaare Zedek Medical Center /ID# 137435, Jerusalem

92093

Ucsd /Id# 140323, La Jolla

92868

Univ CA, Irvine Med Ctr /ID# 139613, Orange

93872

MultiCare Regional Cancer Ctr /ID# 149872, Puyallup

94086

Palo Alto Medical Foundation /ID# 139452, Sunnyvale

94115

California Pacific Medical Ctr /ID# 138177, San Francisco

Kaiser Permanente - San Francisco /ID# 142051, San Francisco

94520

John Muir Medical Center /ID# 139618, Concord

94596

Kaiser Permanente- Walnut Creek /ID# 142052, Walnut Creek

95817

UC Davis Comprehensive Cancer Center - Main /ID# 144439, Sacramento

96813

The Queens Medical Center /ID# 141709, Honolulu

96826

Kapiolani Medical Center /ID# 140319, Honolulu

97227

Kaiser Permanente, NW /ID# 138249, Portland

98273

Skagit Valley Medical Center /ID# 139586, Mount Vernon

98405

Multicare Institute for Research and Innovation /ID# 143485, Tacoma

3109601

Rambam Health Care Campus /ID# 137434, Haifa

3436212

The Lady Davis Carmel MC /ID# 137537, Haifa

4428164

Meir Medical Center /ID# 139397, Kfar Saba

5262100

Sheba Medical Center /ID# 137436, Ramat Gan

5898511

Kindai University Hospital /ID# 154947, Ōsaka-sayama

36604-3302

University of South Alabama /ID# 138091, Mobile

99508-4684

Alaska Womens Cancer Care /ID# 138231, Anchorage

85711-2701

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

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

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

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

85719-1478

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

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

92868-4304

Medical Oncology Care Assoc /ID# 139498, Orange

94143-2204

Univ California, San Francisco /ID# 138178, San Francisco

95051-5173

Kaiser Permanente-Santa Clara /ID# 142053, Santa Clara

94305-2200

Stanford University School of Med /ID# 139450, Stanford

94589-2441

Kaiser Permanente Medical Ctr-Vallejo /ID# 139492, Vallejo

06510

Yale University /ID# 138056, New Haven

33612-9416

Moffitt Cancer Center /ID# 138061, Tampa

31904-8946

IACT Health /ID# 138058, Columbus

60637-1443

University of Chicago /ID# 139612, Chicago

40202-3700

Norton Cancer Institute /ID# 139567, Louisville

04102

MMP Women's Health /ID# 139544, Portland

01199

Baystate Medical Center /ID# 139456, Springfield

01655

UMass Memorial Medical Center /ID# 139458, Worcester

48201-2013

Wayne State University /ID# 139601, Detroit

48073-6710

William Beaumont Hospital /ID# 139550, Royal Oak

55905-0001

Mayo Clinic - Rochester /ID# 139565, Rochester

65212-1000

Ellis Fischel Cancer Center /ID# 139571, Columbia

03756

Dartmouth-Hitchcock Medical Center /ID# 139502, Lebanon

08103

MD Anderson Cancer Ctr at Coop /ID# 139616, Camden

07601

Hackensack Univ Med Ctr /ID# 143776, Hackensack

10032-3729

Columbia University Medical Center /ID# 138252, New York

10065-6007

Memorial Sloan Kettering Cancer Center /ID# 138017, New York

Memorial Sloan Kettering Cancer Center /ID# 154464, New York

27514-4220

Univ NC Chapel Hill /ID# 138547, Chapel Hill

27710-3000

Duke University Medical Center /ID# 138048, Durham

27157-0001

Wake Forest Baptist Medical Center /ID# 139588, Winston-Salem

45267-0585

University of Cincinnati /ID# 139619, Cincinnati

45429-1226

Womens Cancer Center /ID# 138062, Kettering

97401-6043

Willamette Valley Cancer Institute /ID# 140318, Eugene

19104-5502

University of Pennsylvania /ID# 140079, Philadelphia

19107-4414

Thomas Jefferson University /ID# 138239, Philadelphia

02905

Women and Infants Hospital /ID# 138083, Providence

57104-8805

Sanford Research/USD /ID# 139624, Sioux Falls

76104-2150

Texas Oncology - Forth Worth /ID# 143811, Fort Worth

84112-5500

University of Utah /ID# 138250, Salt Lake City

05401-1473

University of Vermont Medical Center /ID# 138251, Burlington

53226-3522

Froedtert & the Medical College of Wisconsin /ID# 139449, Milwaukee

30130-100

Hc Ufmg /Id# 137156, Belo Horizonte

90610-000

Hospital Sao Lucas da PUCRS /ID# 137157, Porto Alegre

14784-400

Hospital de Cancer de Barretos /ID# 137121, Barretos

01317-000

Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120, São Paulo

20231-050

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

464-8681

Aichi Cancer Center Hospital /ID# 148398, Nagoya

811-1395

National Hospital Organization Kyushu Cancer Center /ID# 149133, Fukuoka

830-0011

Kurume University Hospital /ID# 148697, Kurume-shi

028-3695

Iwate Medical University Hospital /ID# 147721, Shiwa-gun

860-8556

Kumamoto University Hospital /ID# 154169, Kumamoto

514-8507

Mie University Hospital /ID# 149169, Tsu

980-8574

Tohoku University Hospital /ID# 149818, Sendai

951-8520

Niigata University Medical & Dental Hospital /ID# 149488, Niigata

411-8777

Shizuoka Cancer Center /ID# 147723, Sunto-gun

135-8550

The Cancer Institute Hosp JFCR /ID# 148436, Koto-ku

160-8582

Keio University Hospital /ID# 148326, Shinjuku-ku

990-9585

Yamagata University Hospital /ID# 153646, Yamagata

673-8558

Hyogo Cancer Center /ID# 148327, Akashi

660-8511

Kansai Rosai Hospital /ID# 149237, Amagasaki

277-0004

The Jikei Univ. Kashiwa Hosp. /ID# 149238, Kashiwa-shi

216-8511

St. Marianna Univ Hospital /ID# 149327, Kawasaki

737-0023

NHO Kure Medical Center and Ch /ID# 148569, Kure

791-0280

Shikoku Cancer Center /ID# 148382, Matsuyama

541-8567

Osaka International Cancer Institute /ID# 150778, Osaka

003-0804

Hokkaido Cancer Center /ID# 148570, Sapporo

105-8461

The Jikei University Hospital /ID# 148691, Tokyo

80-214

Uniwersyteckie C. Kliniczne /ID# 138021, Gdansk

02841

Korea University Anam Hospital /ID# 136908, 성북구

06273

Gangnam Severance Hospital /ID# 136835, Seoul

06351

Samsung Medical Center /ID# 136834, Seoul

03080

Seoul National University Hospital /ID# 136909, Seoul

05505

Asan Medical Center /ID# 136836, Seoul

08907

Hospital Duran i Reynals /ID# 137298, L'Hospitalet de Llobregat

08035

Hospital Univ Vall d'Hebron /ID# 137297, Barcelona

08036

Hospital Clinic de Barcelona /ID# 137300, Barcelona

NR4 7UY

Norfolk and Norwich Univ Hosp /ID# 137969, Norwich

G12 0YN

Beatson west of scotland cancer center /ID# 137965, Glasgow

DD1 9SY

Ninewells Hospital /ID# 137967, Dundee

NR31 6LA

James Paget University Hosp /ID# 137970, Great Yarmouth

W12 0HS

Imanova Limited, Hammersmith Hospital /ID# 137966, London

OX3 7LE

Oxford Univ Hosp NHS Trust /ID# 137973, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Australia New Zealand Gynaecological Oncology Group

OTHER

lead

AbbVie

INDUSTRY