Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation (Veli-BRCA)
The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer|
- Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Phase II: Response rate [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.
The side effects are modest, since PARP inhibitors affect cancer cells to a much larger extent than normal cells. The effect of this PARP-inhibiting treatment is evident although the greatest effect is seen in patients with mutations in BRCA genes. The reason for this is that BRCA deficient cancer cells are unable to repair both DNA double strand and single strand breaks and undergo apoptosis to a large extent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472783
|Department of Oncology, Vejle Hospital|
|Vejle, Denmark, 7100|
|Study Chair:||Anders Jakobsen, DMSc||Vejle Hospital, Vejle, Denmark|