NCT01472783

Veliparib Monotherapy for Relapsed Ovarian Cancer With BRCA Mutation

Veliparib (ABT888) Monotherapy for Patients With BRCA Germline Mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent, Epithelial Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Veliparib	Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-01-01
• Completion: 2016-08-01
• First posted: 2011-11-16
• Last updated: 2016-11-16

Locations

1 site across 1 country: Denmark