Status:
COMPLETED
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Open-label exloratory pharmacodynamic and pharmacogenomic study to evaluate teh biologic effects of 3 dose levels (1mg, 5 mg, and 15 mg) of temsirolimus administered orally once daily for approximatel...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the prostate gland via a minimum of 6 core biopsy samples.
- Subjects must be a candidate for radical prostatectomy
- No evidence of metastatic disease as determined by CT scans and bone scans
- More criteria apply
- Exclusion Criteria:
- Subjects from whom sufficient diagnostic biopsy material is not available for full characterization of the tumor
- Active Infection requiring antibiotic therapy, or serious intercurrent illness, active bleeding, or ongoing urinary tract infection necessitating rapid or emergent surgical resection
- Subjects who have had hormonal injection or implants which will last longer than 6 months
- More criteria apply
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00235794
Start Date
January 1 2004
End Date
September 1 2007
Last Update
December 27 2007
Active Locations (1)
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1
Houston, Texas, United States, 77030