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Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
NCT00005028Phase 2
Key facts
- Status
- Completed
- Start
- May 2000
- Primary completion
- Jul 2006
- Countries
- 1
- Sponsor
- University of Maryland, Baltimore
- Modality
- Small Molecules
- Drugs
- bryostatin-1
- Conditions
- prostate cancer (PCa)
01
Overview
Phase 2, open-label, single-arm trial of bryostatin-1 in prostate cancer (PCa), sponsored by University of Maryland, Baltimore. Primary endpoint: Proportion of patients with >= 50% decrease in PSA at 4 weeks. Started May 2000; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Paclitaxel + Bryostatin 1
Paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment repeats every 4 weeks.
03
Who it enrols
Patients with histologically confirmed metastatic adenocarcinoma of the prostate who have failed first- or second-line hormonal therapy, have castrate levels of testosterone, and no prior chemotherapy.
04
Endpoints
Primary
Proportion of patients with >= 50% decrease in PSA
Secondary
Objective Response Rate
Toxicity
Overall Survival
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