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Veliparib and Topotecan in Recurrent Cervical Cancer
NCT01266447Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2011
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules
- Drugs
- veliparib
- Conditions
- Cervical Cancer (CC)
01
Overview
Phase 2, open-label, single-arm trial of veliparib in Cervical Cancer (CC), sponsored by National Cancer Institute. Primary endpoints: Objective Response Rate at 2.3 months, Dose-limiting Toxicities at 21 days and 1 more. Started Feb 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Veliparib + Topotecan + G-CSF
Veliparib 10 mg PO BID days 1-5, Topotecan 0.6 mg/m^2 IV days 1-5, Filgrastim/Pegfilgrastim SC starting day 6.
03
Who it enrols
Patients with persistent or recurrent cervical cancer who have received one prior systemic chemotherapy regimen and have not received prior PARP inhibitors or topotecan.
04
Endpoints
Primary
Objective Response Rate
Dose-limiting Toxicities
Adverse Events (Grade 3 or Higher)
Secondary
Progression-Free Survival
Overall Survival
Duration of Objective Response
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