NCT01690598

Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients With Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer With Negative or Unknown BRCA Status

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Vejle Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Veliparib	Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.
DRUG	Topotecan	2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2012-09-24
• Last updated: 2015-06-10

Locations

1 site across 1 country: Denmark