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Navitoclax in platinum-resistant ovarian cancer
NCT02591095Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2016
- Primary completion
- Apr 2017
- Countries
- 1
- Sponsor
- Centre François Baclesse
- Modality
- Small Molecules
- Drugs
- navitoclax
- Conditions
- ovarian cancerfallopian tube cancer (PFTC)primary peritoneal cancer (PPC)
01
Overview
Phase 2, open-label, single-arm trial of navitoclax in ovarian cancer, fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC), sponsored by Centre François Baclesse. Primary endpoint: Progression-Free Survival at 12 months. Started Jan 2016; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Navitoclax Monotherapy
Oral Navitoclax daily
03
Who it enrols
Women >18 years with platinum-resistant/refractory high-grade serous ovarian, fallopian tube, or peritoneal cancer, ECOG 0-2, and adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Bim expression level
Response Rate
Overall Survival
Incidence of Treatment-Emergent Adverse Events
Peak Plasma Concentration of ABT-263
Residual concentration of ABT-263
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