18 and older, female only, with BRCA1 Mutation Carrier or BRCA2 Mutation Carrier. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of Patients With Complete and Partial Tumor ResponsePrimary· CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.
Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at \>= 4 weeks); Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions (confirmed at \>= 4 weeks); Overall Response = CR + PR.
Group
Value
95% CI
Treatment (Veliparib)
0.26
0.146 – 0.403
Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0Primary· After every cycle while on study therapy. Followed for late adverse events up to 30 days after completing therapy.
Patients with grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Group
Value
95% CI
Treatment (Veliparib)
0.32
0.195 – 0.467
Duration of PFSSecondary· CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Patients who begin subsequent therapy without progression will be monitored for PFS for 5 years.
The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (and \>= 5 mm increase of target lesions), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Treatment (Veliparib)
8.18
5.45 – 9.63
Duration of OSSecondary· Every cycle while patient is receiving protocol therapy. Patients will be monitored for survival after going off therapy for a 5 year period, every 3 months for the first 2 years, then every 6 months for the last 3 years.
Overall survival
Group
Value
95% CI
Treatment (Veliparib)
NA
13.4 – NA
The Proportion of Patients Who Survive Progression-free for at Least 6 MonthsSecondary· 6 months
This outcome captures whether or not the patient survived progression-free for at least 6 months, and is displayed as a proportion.
Group
Value
95% CI
Treatment (Veliparib)
0.54
0.393 – 0.682
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment (Veliparib)
Serious: 10/50 (20%)
Deaths: 21/50
Serious adverse events (10 terms)
Reaction
System
Treatment (Veliparib)
Small Intestinal Obstruction
Gastrointestinal disorders
—
Abdominal Pain
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Ascites
Gastrointestinal disorders
—
Hepatobiliary Disorders - Other
Hepatobiliary disorders
—
Alanine Aminotransferase Increased
Investigations
—
Dehydration
Metabolism and nutrition disorders
—
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
—
Adult Respiratory Distress Syndrome
Respiratory, thoracic and mediastinal disorders
—
Thromboembolic Event
Vascular disorders
—
Other adverse events (133 terms — click to expand)
This phase II trial studies how well veliparib works in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Other recruiting trials for BRCA1 Mutation Carrier
Currently open trials in the same condition.
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Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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· recruiting
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· Phase 2
· recruiting
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· Phase 1
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NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
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· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 23 July 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01540565.