Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|ClinicalTrials.gov Identifier: NCT01540565|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|BRCA1 Mutation Carrier BRCA2 Mutation Carrier Ovarian Epithelial Tumor Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Other: Laboratory Biomarker Analysis Drug: Veliparib||Phase 2|
I. To estimate the proportion of patients who have objective tumor response (complete or partial).
II. To determine the frequency and severity of adverse events associated with treatment with veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
I. To determine the duration of progression-free survival (PFS) and overall survival (OS).
II. To determine the proportion of patients who survive progression-free for at least 6 months.
I. To explore the association between single nucleotide polymorphisms (SNPs) in deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer [BRCA]1, Fanconi) and clinical characteristics, response, and patient outcome (PFS and OS).
Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation|
|Actual Study Start Date :||April 9, 2012|
|Actual Primary Completion Date :||January 27, 2018|
Experimental: Treatment (veliparib)
Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- The frequency of patients who have objective tumor response [ Time Frame: Up to 5 years ]
- Incidence of adverse effects as assessed by CTCAE v 4.0 [ Time Frame: Up to 5 years ]The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.
- Duration of PFS [ Time Frame: Up to 5 years ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- Duration of OS [ Time Frame: Up to 5 years ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- The proportion of patients who survive progression-free for at least 6 months [ Time Frame: 6 months ]Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
- SNPs with DNA repair genes, tumor response, PFS, OS, and patient demographics (e.g. age, race, tumor grade) [ Time Frame: Baseline ]If the clinical trial goes to the second stage and there is sufficient variability in the SNPs, then patients can be categorized by the nature of their SNPs and assessed for prognostic value through survival analysis (e.g. log-rank tests and Cox proportional hazards modeling). If the variability in SNPs is relatively low, assessment of prognostic value can be conducted with odds ratios of patients responding or surviving progression-free for at least 6 months. These techniques will use exact methods such as Fisher's exact test.
- BRCA mutation in primary tumor tissue [ Time Frame: Baseline ]BRCA mutational status will be tabulated against the germline mutation to see what proportion of patients have a mutation reversal within the tumor and whether such reversals can explain resistance to the regimen under study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540565
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|Principal Investigator:||Robert Coleman||NRG Oncology|