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Ixabepilone in Relapsed/Refractory Ovarian Cancer
NCT00030706Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2004
- Primary completion
- Feb 2007
- Countries
- 1
- Sponsor
- Montefiore Medical Center
- Modality
- Small Molecules
- Drugs
- ixabepilone
- Conditions
- ovarian epithelial cancerprimary peritoneal carcinoma (PPC)
01
Overview
Phase 2, open-label, single-arm trial of ixabepilone in ovarian epithelial cancer and primary peritoneal carcinoma (PPC), sponsored by Montefiore Medical Center. Primary endpoints: Incidence of clinical remission, Progression-Free Survival and 1 more. Started Nov 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Ixabepilone
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every 4 weeks.
03
Who it enrols
Patients with relapsed/refractory stage III/IV ovarian epithelial or primary peritoneal cancer who have received exactly one prior platinum/taxane regimen.
04
Endpoints
Primary
Incidence of clinical remission
Progression-Free Survival
Nature and degree of toxicity
Secondary
Survivin mRNA and protein levels
CYP3A4, 3A5, and 3A7 allelic polymorphisms
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