An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

Prostatic Neoplasms Clinical Trial

Official title:

An Open Label Study of Exploratory Pharmacogenomics and Pharmacologic Effects of Neoadjuvant Oral Temsirolimus in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have a High Risk of Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235794
• Other study ID #: 3066A1-132
• Status: Completed
• Phase: N/A
• First received: October 6, 2005
• Last updated: December 18, 2007
• Start date: January 2004
• Est. completion date: September 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• temsirolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effects of oral temsirolimus on changes in phosphorylation state of proteins in the mTOR signaling pathway in tumor tissue and on phosphorylation state of mTOR pathway proteins and on global and targeted gene expression pattern PBMCs
Secondary	Determine effects of oral temsirolimus on global and targeted gene expression; compare effects in the tumor and PBMCs; obtain preliminary information on potential antitumor effects; evaluate PK using whole blood and tumor tissue.
Secondary	To evaluate the relationship between PTEN status and the pharmacodynamic/pharmacogenomic effects of temsirolimus and to determine the effects of temsirolimus on changes in protein expression patterns in the plasma