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GM-CSF Maintenance in AIPC Responding to Taxotere
NCT00274287Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2006
- Primary completion
- Dec 2010
- Countries
- 1
- Sponsor
- Oncology Specialists
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- sargramostim
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of sargramostim in prostate cancer (PCa), sponsored by Oncology Specialists. Primary endpoint: Time to Disease Progression at 21 months. Started Jan 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
GM-CSF
GM-CSF maintenance therapy
03
Who it enrols
Patients with androgen-independent prostate cancer who have achieved a maximal response on Taxotere or other chemotherapy schedule.
04
Endpoints
Primary
Time to Disease Progression
Secondary
Response Rate (PSA)
Response Rate (Radiographic)
Median Overall Survival
Median Number of GM-CSF Cycles
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