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Docetaxel Extension in Metastatic Hormone Refractory Prostate Cancer
NCT00723086Phase 2
Key facts
- Status
- Completed
- Start
- May 2005
- Primary completion
- Sep 2008
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Small Molecules
- Drugs
- docetaxel
- Conditions
- metastatic castration-resistant prostate cancer (mCRPC)
01
Overview
Phase 2, open-label, single-arm trial of docetaxel in metastatic castration-resistant prostate cancer (mCRPC), sponsored by Sanofi. Primary endpoint: Incidence rate of adverse events up to 37 months. Started May 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Docetaxel + Prednisolone
Docetaxel administered every 3 weeks in combination with daily prednisolone.
03
Who it enrols
Patients with metastatic hormone refractory prostate cancer who completed 10 cycles of docetaxel in the preceding XRP6976J/2101 study without disease progression or unacceptable toxicity.
04
Endpoints
Primary
Incidence rate of adverse events
Secondary
No obvious disease progression
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