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Birinapant in Relapsed Platinum Resistant Ovarian Cancer
NCT01681368Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2012
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Small Molecules, Modified Peptides
- Drugs
- birinapant
- Conditions
- epithelial ovarian cancer (EOC)primary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
01
Overview
Phase 2, open-label, single-arm trial of birinapant in epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC), sponsored by National Cancer Institute. Primary endpoint: Objective Response (CR or PR) or Disease Stabilization for Greater Than 6 Months. Started Aug 2012; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Birinapant Monotherapy
Birinapant 47mg/m^2 IV weekly for 3 weeks followed by 1 week rest (4-week cycle).
03
Who it enrols
Adult females with relapsed/refractory platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancer, ECOG 0-2, and adequate organ function.
04
Endpoints
Primary
Objective Response (CR or PR) or Disease Stabilization for Greater Than 6 Months
Secondary
Number of Participants With Adverse Events
Mean Plasma Concentration-Time Curve of Birinapant
Birinapant Concentration in Tumor Tissue
Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Tumor Tissue
Calculated Volume of Distribution of Birinapant at Steady State (Vss) in Plasma
Ratio of Phosphorylated NF-kappaB-p65 Protein to Total NF-kappaBp65 Protein in Tumor Biopsy Samples
Coexpression of Cleaved Caspase 3 and Gamma-H2AX in Fixed Specimens
Total Clearance of Birinapant After Administration
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