Study Stopped
Business decision not related to patient safety
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
2 other identifiers
interventional
1,140
11 countries
210
Brief Summary
The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel \[C/P\]) and continued as maintenance therapy compared with chemotherapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
Started Jul 2015
Longer than P75 for phase_3 ovarian-cancer
210 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedStudy Start
First participant enrolled
July 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2019
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2023
CompletedOctober 26, 2024
October 1, 2024
3.8 years
June 10, 2015
August 4, 2020
October 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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 (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. .
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 (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.
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)
Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)
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 (Arm 2 vs Arm 1)
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 (Arm 2 vs Arm 1)
From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Overall Survival (OS) in the BRCA-deficient Population
From the time of randomization to the end of the study, up to 98 months
Overall Survival (OS) in the Homologous Recombination Deficiency Population
From the time of randomization to the end of the study, up to 98 months
- +4 more secondary outcomes
Study Arms (3)
Placebo + Carboplatin + Paclitaxel -> Placebo
ACTIVE 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.
Veliparib + Carboplatin + Paclitaxel -> Placebo
EXPERIMENTALParticipants 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.
Veliparib + Carboplatin + Paclitaxel -> Veliparib
EXPERIMENTALParticipants 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.
Interventions
Capsules for oral administration
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).
Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.
Capsules for oral administration
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Australia New Zealand Gynaecological Oncology Groupcollaborator
Study Sites (210)
University of Alabama at Birmingham - Main /ID# 138087
Birmingham, Alabama, 35233, United States
Tennessee Valley Gyn-Onc /ID# 139548
Huntsville, Alabama, 35805, United States
University of South Alabama /ID# 138091
Mobile, Alabama, 36604-3302, United States
Alaska Womens Cancer Care /ID# 138231
Anchorage, Alaska, 99508-4684, United States
Arizona Oncology Associates, PC-HOPE /ID# 142002
Tucson, Arizona, 85711-2701, United States
Arizona Oncology Associates, PC-HOPE /ID# 143805
Tucson, Arizona, 85711-2701, United States
Arizona Oncology Associates, PC-HOPE /ID# 143806
Tucson, Arizona, 85711-2701, United States
Arizona Oncology Associates, PC-HOPE /ID# 143808
Tucson, Arizona, 85711-2701, United States
University of Arizona Cancer Center - North Campus /ID# 138084
Tucson, Arizona, 85719-1478, United States
University of Arizona Cancer Center - North Campus /ID# 139495
Tucson, Arizona, 85719-1478, United States
University of Arkansas for Medical Sciences /ID# 138253
Little Rock, Arkansas, 72205, United States
John Muir Medical Center /ID# 139618
Concord, California, 94520, United States
Ucsd /Id# 140323
La Jolla, California, 92093, United States
Long Beach Memorial Medical Ct /ID# 147526
Long Beach, California, 90806, United States
Kaiser Permanente /ID# 141305
Los Angeles, California, 90027, United States
University of California, Los Angeles /ID# 138179
Los Angeles, California, 90095, United States
Medical Oncology Care Assoc /ID# 139498
Orange, California, 92868-4304, United States
Univ CA, Irvine Med Ctr /ID# 139613
Orange, California, 92868, United States
UC Davis Comprehensive Cancer Center - Main /ID# 144439
Sacramento, California, 95817, United States
California Pacific Medical Ctr /ID# 138177
San Francisco, California, 94115, United States
Kaiser Permanente - San Francisco /ID# 142051
San Francisco, California, 94115, United States
Univ California, San Francisco /ID# 138178
San Francisco, California, 94143-2204, United States
Kaiser Permanente-Santa Clara /ID# 142053
Santa Clara, California, 95051-5173, United States
Stanford University School of Med /ID# 139450
Stanford, California, 94305-2200, United States
Palo Alto Medical Foundation /ID# 139452
Sunnyvale, California, 94086, United States
Kaiser Permanente Medical Ctr-Vallejo /ID# 139492
Vallejo, California, 94589-2441, United States
Kaiser Permanente- Walnut Creek /ID# 142052
Walnut Creek, California, 94596, United States
Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499
Aurora, Colorado, 80014, United States
Univ of Colorado Cancer Center /ID# 138016
Aurora, Colorado, 80045, United States
Hartford Healthcare /ID# 138184
New Britain, Connecticut, 6053, United States
Yale University /ID# 138056
New Haven, Connecticut, 06510, United States
University of Miami /ID# 139457
Miami, Florida, 33136, United States
Sarasota Memorial Health Care /ID# 138180
Sarasota, Florida, 34239, United States
Women's Cancer Associates /ID# 140321
St. Petersburg, Florida, 33701, United States
Moffitt Cancer Center /ID# 138061
Tampa, Florida, 33612-9416, United States
Georgia Regents University /ID# 138085
Augusta, Georgia, 30912, United States
IACT Health /ID# 138058
Columbus, Georgia, 31904-8946, United States
Memorial Health Univ Med Ctr /ID# 138019
Savannah, Georgia, 31404, United States
St. Joseph's/Candler /ID# 138090
Savannah, Georgia, 31405, United States
The Queens Medical Center /ID# 141709
Honolulu, Hawaii, 96813, United States
Kapiolani Medical Center /ID# 140319
Honolulu, Hawaii, 96826, United States
Rush University Medical Center /ID# 143491
Chicago, Illinois, 60612, United States
University of Chicago /ID# 139612
Chicago, Illinois, 60637-1443, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 139451
Evanston, Illinois, 60201, United States
Sharma, Hinsdale, IL /ID# 140326
Hinsdale, Illinois, 60521, United States
Advocate Lutheran General Hosp /ID# 139489
Park Ridge, Illinois, 60068, United States
Indiana Univ School Medicine /ID# 139610
Indianapolis, Indiana, 46202, United States
Saint Vincent /ID# 139537
Indianapolis, Indiana, 46260, United States
McFarland Clinic, PC /ID# 139455
Ames, Iowa, 50010, United States
University of Iowa Hospitals and Clinics /ID# 138082
Iowa City, Iowa, 52242, United States
Univ Kansas Med Ctr /ID# 140322
Kansas City, Kansas, 66160, United States
Baptist Health Lexington /ID# 139542
Lexington, Kentucky, 40503, United States
University of Kentucky Chandler Medical Center /ID# 138060
Lexington, Kentucky, 40536, United States
Norton Cancer Institute /ID# 139567
Louisville, Kentucky, 40202-3700, United States
MMP Women's Health /ID# 139544
Portland, Maine, 04102, United States
Greater Baltimore Medical Ctr /ID# 138049
Baltimore, Maryland, 21204, United States
Sinai Hospital of Baltimore /ID# 141306
Baltimore, Maryland, 21215, United States
Weinberg Cancer Inst Franklin /ID# 138235
Rossville, Maryland, 21237, United States
Baystate Medical Center /ID# 139456
Springfield, Massachusetts, 01199, United States
UMass Memorial Medical Center /ID# 139458
Worcester, Massachusetts, 01655, United States
Wayne State University /ID# 139601
Detroit, Michigan, 48201-2013, United States
Henry Ford Health System /ID# 139536
Detroit, Michigan, 48202, United States
William Beaumont Hospital /ID# 139550
Royal Oak, Michigan, 48073-6710, United States
Mayo Clinic - Rochester /ID# 139565
Rochester, Minnesota, 55905-0001, United States
Mmcorc /Id# 139534
Saint Louis Park, Minnesota, 55416, United States
St. Dominic Hospital /ID# 138241
Jackson, Mississippi, 39216, United States
Ellis Fischel Cancer Center /ID# 139571
Columbia, Missouri, 65212-1000, United States
Cancer Research For the Ozarks /ID# 139538
Springfield, Missouri, 65804, United States
Ferrell-Duncan Clinic /ID# 143484
Springfield, Missouri, 65807, United States
Washington University-School of Medicine /ID# 138089
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital /ID# 139600
Omaha, Nebraska, 68114, United States
Womens Cancer Center of Nevada /ID# 138092
Las Vegas, Nevada, 89169, United States
Renown Regional Medical Center /ID# 138237
Reno, Nevada, 89502, United States
Dartmouth-Hitchcock Medical Center /ID# 139502
Lebanon, New Hampshire, 03756, United States
MD Anderson Cancer Ctr at Coop /ID# 139616
Camden, New Jersey, 08103, United States
Hackensack Univ Med Ctr /ID# 143776
Hackensack, New Jersey, 07601, United States
University of New Mexico /ID# 144220
Albuquerque, New Mexico, 87102, United States
SW Gynecologic Oncology Assoc /ID# 147097
Albuquerque, New Mexico, 87106, United States
Women's Cancer Care Associates /ID# 138234
Albany, New York, 12208, United States
SUNY Downstate Medical Center /ID# 139533
Brooklyn, New York, 11203, United States
Roswell Park Comprehensive Cancer Center /ID# 138052
Buffalo, New York, 14263, United States
Northwell Health /ID# 139572
Lake Success, New York, 11042, United States
Icahn School of Med Mt. Sinai /ID# 139617
New York, New York, 10029, United States
Columbia University Medical Center /ID# 138252
New York, New York, 10032-3729, United States
Memorial Sloan Kettering Cancer Center /ID# 138017
New York, New York, 10065-6007, United States
Memorial Sloan Kettering Cancer Center /ID# 154464
New York, New York, 10065-6007, United States
SUNY Upstate Medical University - Downtown /ID# 139513
Syracuse, New York, 13210, United States
Montefiore Medical Center /ID# 139585
The Bronx, New York, 10461, United States
Hope Womens Cancer Centers /ID# 139614
Asheville, North Carolina, 28816, United States
Univ NC Chapel Hill /ID# 138547
Chapel Hill, North Carolina, 27514-4220, United States
Atrium Health Carolinas Medical Center /ID# 139568
Charlotte, North Carolina, 28203, United States
Presbyterian Cancer Center /ID# 139590
Charlotte, North Carolina, 28204, United States
Duke University Medical Center /ID# 138048
Durham, North Carolina, 27710-3000, United States
Wake Forest Baptist Medical Center /ID# 139588
Winston-Salem, North Carolina, 27157-0001, United States
University of Cincinnati /ID# 139619
Cincinnati, Ohio, 45267-0585, United States
Univ Hosp Cleveland /ID# 139615
Cleveland, Ohio, 44106, United States
Fairview Hospital /ID# 144403
Cleveland, Ohio, 44111, United States
Cleveland Clinic Main Campus /ID# 139501
Cleveland, Ohio, 44195, United States
The Ohio State University - Columbus /ID# 138053
Columbus, Ohio, 43210, United States
Columbus NCORP /ID# 139587
Columbus, Ohio, 43215, United States
Womens Cancer Center /ID# 138062
Kettering, Ohio, 45429-1226, United States
Hillcrest Hospital /ID# 144404
Mayfield Heights, Ohio, 44124, United States
Univ Oklahoma HSC /ID# 138020
Oklahoma City, Oklahoma, 73104, United States
Oklahoma Cancer Specialists /ID# 138059
Tulsa, Oklahoma, 74146, United States
Willamette Valley Cancer Institute /ID# 140318
Eugene, Oregon, 97401-6043, United States
Kaiser Permanente, NW /ID# 138249
Portland, Oregon, 97227, United States
Abington Memorial Hospital /ID# 138086
Abington, Pennsylvania, 19001, United States
University of Pennsylvania /ID# 140079
Philadelphia, Pennsylvania, 19104-5502, United States
Thomas Jefferson University /ID# 138239
Philadelphia, Pennsylvania, 19107-4414, United States
Fox Chase Cancer Center /ID# 149479
Philadelphia, Pennsylvania, 19111, United States
University of Pittsburgh MC /ID# 138054
Pittsburgh, Pennsylvania, 15260, United States
Reading Hospital /ID# 138057
Reading, Pennsylvania, 19611, United States
Women and Infants Hospital /ID# 138083
Providence, Rhode Island, 02905, United States
Medical University of South Carolina /ID# 138181
Charleston, South Carolina, 29425, United States
Sanford Research/USD /ID# 139624
Sioux Falls, South Dakota, 57104-8805, United States
Chattanoogas Program in Womens /ID# 139545
Chattanooga, Tennessee, 37403, United States
Texas Oncology - Austin Central /ID# 143817
Austin, Texas, 78731, United States
Texas Oncology - South Austin /ID# 143818
Austin, Texas, 78745, United States
Texas Oncology - Bedford /ID# 143814
Bedford, Texas, 76022, United States
Texas Oncology - Medical City Dallas /ID# 143809
Dallas, Texas, 75230, United States
Texas Oncology - Medical City Dallas /ID# 143812
Dallas, Texas, 75230, United States
Texas Oncology - Forth Worth /ID# 143811
Fort Worth, Texas, 76104-2150, United States
Houston Methodist Hospital - Scurlock Tower /ID# 138232
Houston, Texas, 77030, United States
Memorial Hermann Hospital /ID# 138238
Houston, Texas, 77030, United States
Texas Oncology - The Woodlands /ID# 142003
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler /ID# 143810
Tyler, Texas, 75702, United States
University of Utah /ID# 138250
Salt Lake City, Utah, 84112-5500, United States
University of Vermont Medical Center /ID# 138251
Burlington, Vermont, 05401-1473, United States
University of Virginia /ID# 138088
Charlottesville, Virginia, 22908, United States
Carilion Roanoke Memorial Hosp /ID# 139602
Roanoke, Virginia, 24014, United States
Skagit Valley Medical Center /ID# 139586
Mount Vernon, Washington, 98273, United States
MultiCare Regional Cancer Ctr /ID# 149872
Puyallup, Washington, 93872, United States
Multicare Institute for Research and Innovation /ID# 143485
Tacoma, Washington, 98405, United States
HSHS St. Vincent Hospital /ID# 139453
Green Bay, Wisconsin, 54301, United States
Froedtert & the Medical College of Wisconsin /ID# 139449
Milwaukee, Wisconsin, 53226-3522, United States
Coffs Harbour Health Campus /ID# 145132
Coffs Harbour, New South Wales, 2450, Australia
Gosford Hospital /ID# 145299
Gosford, New South Wales, 2250, Australia
St George Hospital /ID# 145138
Kogarah, New South Wales, 2217, Australia
Newcastle Private Hospital /ID# 145834
Lambton Heights, New South Wales, 2305, Australia
The Prince of Wales Hospital /ID# 145134
Randwick, New South Wales, 2031, Australia
Northern Cancer Institute /ID# 145681
St Leonards, New South Wales, 2065, Australia
Calvary Mater Newcastle /ID# 145139
Waratah, New South Wales, 2298, Australia
Westmead Hospital /ID# 145137
Westmead, New South Wales, 2145, Australia
Southern Medical Day Care Ctr /ID# 145133
Wollongong, New South Wales, 2500, Australia
The Townsville Hospital /ID# 149163
Douglas, Queensland, 4814, Australia
Royal Brisbane and Women's Hospital /ID# 145135
Herston, Queensland, 4029, Australia
Icon Cancer Centre /ID# 148208
South Brisbane, Queensland, 4101, Australia
Mater Misericordiae Limited /ID# 145682
South Brisbane, Queensland, 4101, Australia
Royal Adelaide Hospital /ID# 150071
Adelaide, South Australia, 5000, Australia
Monash Health /ID# 145297
Clayton, Victoria, 3168, Australia
Cabrini Health /ID# 145142
Malvern, Victoria, 3144, Australia
Royal Womens Hospital /ID# 145136
Parkville, Victoria, 3052, Australia
Sir Charles Gairdner Hospital /ID# 145140
Nedlands, Western Australia, 6009, Australia
St. John of God Subiaco Hosp /ID# 147742
Subiaco, Western Australia, 6008, Australia
Hc Ufmg /Id# 137156
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital Sao Lucas da PUCRS /ID# 137157
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital de Cancer de Barretos /ID# 137121
Barretos, São Paulo, 14784-400, Brazil
Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120
São Paulo, São Paulo, 01317-000, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155
Rio de Janeiro, 20231-050, Brazil
Vejle Sygehus /ID# 137262
Vejle, Region Syddanmark, 7100, Denmark
Regionshospitalet Herning /ID# 137260
Herning, 7400, Denmark
Rambam Health Care Campus /ID# 137434
Haifa, 3109601, Israel
The Lady Davis Carmel MC /ID# 137537
Haifa, 3436212, Israel
Shaare Zedek Medical Center /ID# 137435
Jerusalem, 91031, Israel
Meir Medical Center /ID# 139397
Kfar Saba, 4428164, Israel
Sheba Medical Center /ID# 137436
Ramat Gan, 5262100, Israel
Kaplan Medical Center /ID# 137536
Rehovot, 76100, Israel
Aichi Cancer Center Hospital /ID# 148398
Nagoya, Aichi-ken, 464-8681, Japan
National Hospital Organization Kyushu Cancer Center /ID# 149133
Fukuoka, Fukuoka, 811-1395, Japan
Kurume University Hospital /ID# 148697
Kurume-shi, Fukuoka, 830-0011, Japan
Iwate Medical University Hospital /ID# 147721
Shiwa-gun, Iwate, 028-3695, Japan
Kumamoto University Hospital /ID# 154169
Kumamoto, Kumamoto, 860-8556, Japan
Mie University Hospital /ID# 149169
Tsu, Mie-ken, 514-8507, Japan
Tohoku University Hospital /ID# 149818
Sendai, Miyagi, 980-8574, Japan
Niigata University Medical & Dental Hospital /ID# 149488
Niigata, Niigata, 951-8520, Japan
Kindai University Hospital /ID# 154947
Ōsaka-sayama, Osaka, 5898511, Japan
Shizuoka Cancer Center /ID# 147723
Sunto-gun, Shizuoka, 411-8777, Japan
The Cancer Institute Hosp JFCR /ID# 148436
Koto-ku, Tokyo, 135-8550, Japan
Keio University Hospital /ID# 148326
Shinjuku-ku, Tokyo, 160-8582, Japan
Yamagata University Hospital /ID# 153646
Yamagata, Yamagata, 990-9585, Japan
Hyogo Cancer Center /ID# 148327
Akashi, 673-8558, Japan
Kansai Rosai Hospital /ID# 149237
Amagasaki, 660-8511, Japan
The Jikei Univ. Kashiwa Hosp. /ID# 149238
Kashiwa-shi, 277-0004, Japan
St. Marianna Univ Hospital /ID# 149327
Kawasaki, 216-8511, Japan
NHO Kure Medical Center and Ch /ID# 148569
Kure, 737-0023, Japan
Shikoku Cancer Center /ID# 148382
Matsuyama, 791-0280, Japan
Osaka International Cancer Institute /ID# 150778
Osaka, 541-8567, Japan
Hokkaido Cancer Center /ID# 148570
Sapporo, 003-0804, Japan
The Jikei University Hospital /ID# 148691
Tokyo, 105-8461, Japan
Auckland City Hospital /ID# 145123
Auckland, 1023, New Zealand
Uniwersyteckie C. Kliniczne /ID# 138021
Gdansk, 80-214, Poland
National Cancer Center /ID# 139404
Goyang, Gyeonggido, 10408, South Korea
Korea University Anam Hospital /ID# 136908
성북구, Gyeonggido, 02841, South Korea
Gangnam Severance Hospital /ID# 136835
Seoul, Seoul Teugbyeolsi, 06273, South Korea
Samsung Medical Center /ID# 136834
Seoul, Seoul Teugbyeolsi, 06351, South Korea
Seoul National University Hospital /ID# 136909
Seoul, 03080, South Korea
Asan Medical Center /ID# 136836
Seoul, 05505, South Korea
Hospital Duran i Reynals /ID# 137298
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Univ Vall d'Hebron /ID# 137297
Barcelona, 08035, Spain
Hospital Clinic de Barcelona /ID# 137300
Barcelona, 08036, Spain
Hospital Clin Univ San Carlos /ID# 137402
Madrid, 28040, Spain
Hosp Univ 12 de Octubre /ID# 137299
Madrid, 28041, Spain
Hosp Univ Madrid Sanchinarro /ID# 137414
Madrid, 28050, Spain
Fundacion Inst Valenciano Onc /ID# 137403
Valencia, 46009, Spain
Norfolk and Norwich Univ Hosp /ID# 137969
Norwich, Norfolk, NR4 7UY, United Kingdom
Beatson west of scotland cancer center /ID# 137965
Glasgow, Scotland, G12 0YN, United Kingdom
Ninewells Hospital /ID# 137967
Dundee, DD1 9SY, United Kingdom
James Paget University Hosp /ID# 137970
Great Yarmouth, NR31 6LA, United Kingdom
Imanova Limited, Hammersmith Hospital /ID# 137966
London, W12 0HS, United Kingdom
Oxford Univ Hosp NHS Trust /ID# 137973
Oxford, OX3 7LE, United Kingdom
Related Publications (4)
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.
PMID: 31562800BACKGROUNDSwisher 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.
PMID: 34906376DERIVEDWashington 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.
PMID: 33369580DERIVEDNishikawa 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.
PMID: 28665051DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2015
First Posted
June 12, 2015
Study Start
July 14, 2015
Primary Completion
May 3, 2019
Study Completion
October 5, 2023
Last Updated
October 26, 2024
Results First Posted
September 14, 2020
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing, please refer to the link below.
- 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.
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.