An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Male

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 approximately 4 weeks (+/- 2 weeks) before prostatectomy

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Sirolimus

Criteria

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