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An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00235794
First received: October 6, 2005
Last updated: December 18, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention
Prostatic Neoplasms
 Drug: temsirolimus

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.
  • 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

Estimated Enrollment: 50
Study Start Date: January 2004
Study Completion Date: September 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235794

Locations
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235794     History of Changes
Other Study ID Numbers: 3066A1-132
Study First Received: October 6, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 21, 2013