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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)

Primary Purpose

Ovarian Cancer, Ovarian Neoplasm

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Veliparib
Paclitaxel
Carboplatin
Placebo to Veliparib
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Veliparib, Carboplatin, Paclitaxel, Overall Survival, ABT-888, Randomized, Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP), Ovarian, BRCA, VELIA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 138087
  • Tennessee Valley Gyn-Onc /ID# 139548
  • University of South Alabama /ID# 138091
  • Alaska Womens Cancer Care /ID# 138231
  • Arizona Oncology Associates, PC-HOPE /ID# 142002
  • Arizona Oncology Associates, PC-HOPE /ID# 143805
  • Arizona Oncology Associates, PC-HOPE /ID# 143806
  • Arizona Oncology Associates, PC-HOPE /ID# 143808
  • University of Arizona Cancer Center - North Campus /ID# 138084
  • University of Arizona Cancer Center - North Campus /ID# 139495
  • University of Arkansas for Medical Sciences /ID# 138253
  • John Muir Medical Center /ID# 139618
  • Ucsd /Id# 140323
  • Long Beach Memorial Medical Ct /ID# 147526
  • Kaiser Permanente /ID# 141305
  • University of California, Los Angeles /ID# 138179
  • Medical Oncology Care Assoc /ID# 139498
  • Univ CA, Irvine Med Ctr /ID# 139613
  • UC Davis Comprehensive Cancer Center - Main /ID# 144439
  • California Pacific Medical Ctr /ID# 138177
  • Kaiser Permanente - San Francisco /ID# 142051
  • Univ California, San Francisco /ID# 138178
  • Kaiser Permanente-Santa Clara /ID# 142053
  • Stanford University School of Med /ID# 139450
  • Palo Alto Medical Foundation /ID# 139452
  • Kaiser Permanente Medical Ctr-Vallejo /ID# 139492
  • Kaiser Permanente- Walnut Creek /ID# 142052
  • Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499
  • Univ of Colorado Cancer Center /ID# 138016
  • Hartford Healthcare /ID# 138184
  • Yale University /ID# 138056
  • University of Miami /ID# 139457
  • Women's Cancer Associates /ID# 140321
  • Sarasota Memorial Health Care /ID# 138180
  • Moffitt Cancer Center /ID# 138061
  • Georgia Regents University /ID# 138085
  • IACT Health /ID# 138058
  • Memorial Health Univ Med Ctr /ID# 138019
  • St. Joseph's/Candler /ID# 138090
  • The Queens Medical Center /ID# 141709
  • Kapiolani Medical Center /ID# 140319
  • Rush University Medical Center /ID# 143491
  • University of Chicago /ID# 139612
  • NorthShore University HealthSystem - Evanston Hospital /ID# 139451
  • Sharma, Hinsdale, IL /ID# 140326
  • Advocate Lutheran General Hosp /ID# 139489
  • Indiana Univ School Medicine /ID# 139610
  • Saint Vincent /ID# 139537
  • McFarland Clinic, PC /ID# 139455
  • University of Iowa Hospitals and Clinics /ID# 138082
  • Univ Kansas Med Ctr /ID# 140322
  • Baptist Health Lexington /ID# 139542
  • University of Kentucky Chandler Medical Center /ID# 138060
  • Norton Cancer Institute /ID# 139567
  • MMP Women's Health /ID# 139544
  • Greater Baltimore Medical Ctr /ID# 138049
  • Sinai Hospital of Baltimore /ID# 141306
  • Weinberg Cancer Inst Franklin /ID# 138235
  • Baystate Medical Center /ID# 139456
  • UMass Memorial Medical Center /ID# 139458
  • Wayne State University /ID# 139601
  • Henry Ford Health System /ID# 139536
  • William Beaumont Hospital /ID# 139550
  • Mayo Clinic - Rochester /ID# 139565
  • Mmcorc /Id# 139534
  • St. Dominic Hospital /ID# 138241
  • Ellis Fischel Cancer Center /ID# 139571
  • Washington University-School of Medicine /ID# 138089
  • Cancer Research For the Ozarks /ID# 139538
  • Ferrell-Duncan Clinic /ID# 143484
  • Nebraska Methodist Hospital /ID# 139600
  • Womens Cancer Center of Nevada /ID# 138092
  • Renown Regional Medical Center /ID# 138237
  • Dartmouth-Hitchcock Medical Center /ID# 139502
  • MD Anderson Cancer Ctr at Coop /ID# 139616
  • Hackensack Univ Med Ctr /ID# 143776
  • University of New Mexico /ID# 144220
  • SW Gynecologic Oncology Assoc /ID# 147097
  • Women's Cancer Care Associates /ID# 138234
  • Montefiore Medical Center /ID# 139585
  • SUNY Downstate Medical Center /ID# 139533
  • Roswell Park Comprehensive Cancer Center /ID# 138052
  • Northwell Health /ID# 139572
  • Icahn School of Med Mt. Sinai /ID# 139617
  • Columbia University Medical Center /ID# 138252
  • Memorial Sloan Kettering Cancer Center /ID# 138017
  • Memorial Sloan Kettering Cancer Center /ID# 154464
  • SUNY Upstate Medical University - Downtown /ID# 139513
  • Hope Womens Cancer Centers /ID# 139614
  • Univ NC Chapel Hill /ID# 138547
  • Atrium Health Carolinas Medical Center /ID# 139568
  • Presbyterian Cancer Center /ID# 139590
  • Duke University Medical Center /ID# 138048
  • Wake Forest Baptist Medical Center /ID# 139588
  • University of Cincinnati /ID# 139619
  • Univ Hosp Cleveland /ID# 139615
  • Fairview Hospital /ID# 144403
  • Cleveland Clinic Main Campus /ID# 139501
  • The Ohio State University - Columbus /ID# 138053
  • Columbus NCORP /ID# 139587
  • Womens Cancer Center /ID# 138062
  • Hillcrest Hospital /ID# 144404
  • Univ Oklahoma HSC /ID# 138020
  • Oklahoma Cancer Specialists /ID# 138059
  • Willamette Valley Cancer Institute /ID# 140318
  • Kaiser Permanente, NW /ID# 138249
  • Abington Memorial Hospital /ID# 138086
  • University of Pennsylvania /ID# 140079
  • Thomas Jefferson University /ID# 138239
  • Fox Chase Cancer Center /ID# 149479
  • University of Pittsburgh MC /ID# 138054
  • Reading Hospital /ID# 138057
  • Women and Infants Hospital /ID# 138083
  • Medical University of South Carolina /ID# 138181
  • Sanford Research/USD /ID# 139624
  • Chattanoogas Program in Womens /ID# 139545
  • Texas Oncology - Austin Central /ID# 143817
  • Texas Oncology - South Austin /ID# 143818
  • Texas Oncology - Bedford /ID# 143814
  • Texas Oncology - Medical City Dallas /ID# 143809
  • Texas Oncology - Medical City Dallas /ID# 143812
  • Texas Oncology - Forth Worth /ID# 143811
  • Houston Methodist Hospital - Scurlock Tower /ID# 138232
  • Memorial Hermann Hospital /ID# 138238
  • Texas Oncology - The Woodlands /ID# 142003
  • Texas Oncology - Tyler /ID# 143810
  • University of Utah /ID# 138250
  • University of Vermont Medical Center /ID# 138251
  • University of Virginia /ID# 138088
  • Carilion Roanoke Memorial Hosp /ID# 139602
  • Skagit Valley Medical Center /ID# 139586
  • MultiCare Regional Cancer Ctr /ID# 149872
  • Multicare Institute for Research and Innovation /ID# 143485
  • HSHS St. Vincent Hospital /ID# 139453
  • Froedtert & the Medical College of Wisconsin /ID# 139449
  • Coffs Harbour Health Campus /ID# 145132
  • Gosford Hospital /ID# 145299
  • St George Hospital /ID# 145138
  • Newcastle Private Hospital /ID# 145834
  • The Prince of Wales Hospital /ID# 145134
  • Northern Cancer Institute /ID# 145681
  • Calvary Mater Newcastle /ID# 145139
  • Westmead Hospital /ID# 145137
  • Southern Medical Day Care Ctr /ID# 145133
  • The Townsville Hospital /ID# 149163
  • Royal Brisbane and Women's Hospital /ID# 145135
  • Icon Cancer Centre /ID# 148208
  • Mater Misericordiae Limited /ID# 145682
  • Royal Adelaide Hospital /ID# 150071
  • Monash Health /ID# 145297
  • Cabrini Health /ID# 145142
  • Royal Womens Hospital /ID# 145136
  • Sir Charles Gairdner Hospital /ID# 145140
  • St. John of God Subiaco Hosp /ID# 147742
  • Hc Ufmg /Id# 137156
  • Hospital Sao Lucas da PUCRS /ID# 137157
  • Hospital de Cancer de Barretos /ID# 137121
  • Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120
  • Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155
  • Vejle Sygehus /ID# 137262
  • Regionshospitalet Herning /ID# 137260
  • Rambam Health Care Campus /ID# 137434
  • The Lady Davis Carmel MC /ID# 137537
  • Shaare Zedek Medical Center /ID# 137435
  • Meir Medical Center /ID# 139397
  • Sheba Medical Center /ID# 137436
  • Kaplan Medical Center /ID# 137536
  • Aichi Cancer Center Hospital /ID# 148398
  • National Hospital Organization Kyushu Cancer Center /ID# 149133
  • Kurume University Hospital /ID# 148697
  • Iwate Medical University Hospital /ID# 147721
  • Kumamoto University Hospital /ID# 154169
  • Mie University Hospital /ID# 149169
  • Tohoku University Hospital /ID# 149818
  • Niigata University Medical & Dental Hospital /ID# 149488
  • Kindai University Hospital /ID# 154947
  • Shizuoka Cancer Center /ID# 147723
  • The Cancer Institute Hosp JFCR /ID# 148436
  • Keio University Hospital /ID# 148326
  • Yamagata University Hospital /ID# 153646
  • Hyogo Cancer Center /ID# 148327
  • Kansai Rosai Hospital /ID# 149237
  • The Jikei Univ. Kashiwa Hosp. /ID# 149238
  • St. Marianna Univ Hospital /ID# 149327
  • NHO Kure Medical Center and Ch /ID# 148569
  • Shikoku Cancer Center /ID# 148382
  • Osaka International Cancer Institute /ID# 150778
  • Hokkaido Cancer Center /ID# 148570
  • The Jikei University Hospital /ID# 148691
  • National Cancer Center /ID# 139404
  • Korea University Anam Hospital /ID# 136908
  • Gangnam Severance Hospital /ID# 136835
  • Samsung Medical Center /ID# 136834
  • Seoul National University Hospital /ID# 136909
  • Asan Medical Center /ID# 136836
  • Auckland City Hospital /ID# 145123
  • Uniwersyteckie C. Kliniczne /ID# 138021
  • Hospital Duran i Reynals /ID# 137298
  • Hospital Univ Vall d'Hebron /ID# 137297
  • Hospital Clinic de Barcelona /ID# 137300
  • Hospital Clin Univ San Carlos /ID# 137402
  • Hosp Univ 12 de Octubre /ID# 137299
  • Hosp Univ Madrid Sanchinarro /ID# 137414
  • Fundacion Inst Valenciano Onc /ID# 137403
  • Norfolk and Norwich Univ Hosp /ID# 137969
  • Beatson west of scotland cancer center /ID# 137965
  • Ninewells Hospital /ID# 137967
  • James Paget University Hosp /ID# 137970
  • Imanova Limited, Hammersmith Hospital /ID# 137966
  • Oxford Univ Hosp NHS Trust /ID# 137973

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Placebo + Carboplatin + Paclitaxel -> Placebo

Veliparib + Carboplatin + Paclitaxel -> Placebo

Veliparib + Carboplatin + Paclitaxel -> Veliparib

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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. .
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 10, 2015
Last Updated
June 27, 2023
Sponsor
AbbVie
Collaborators
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT02470585
Brief Title
Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Acronym
VELIA
Official Title
A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 29, 2015 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
October 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
Collaborators
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone.
Detailed Description
Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world [ROW]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown). Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator. The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Ovarian Neoplasm
Keywords
Veliparib, Carboplatin, Paclitaxel, Overall Survival, ABT-888, Randomized, Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP), Ovarian, BRCA, VELIA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo + Carboplatin + Paclitaxel -> Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Veliparib + Carboplatin + Paclitaxel -> Placebo
Arm Type
Experimental
Arm Description
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.
Arm Title
Veliparib + Carboplatin + Paclitaxel -> Veliparib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Veliparib
Other Intervention Name(s)
ABT-888
Intervention Description
Capsules for oral administration
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo to Veliparib
Intervention Description
Capsules for oral administration
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) in the BRCA-deficient Population
Description
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.
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.
Title
Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort
Description
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. .
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.
Title
Progression-Free Survival (PFS) in the Intention-to-treat Population
Description
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.
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.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Approximately 8 years from randomization.
Title
Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
Description
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.
Time Frame
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Title
Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
Description
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.
Time Frame
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Title
Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population
Description
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.
Time Frame
Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Citations:
PubMed Identifier
31562800
Citation
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.
Results Reference
background
PubMed Identifier
34906376
Citation
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.
Results Reference
derived
PubMed Identifier
33369580
Citation
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.
Results Reference
derived
PubMed Identifier
28665051
Citation
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.
Results Reference
derived

Learn more about this trial

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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