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Trial record 1 of 1 for:    NCT00235794
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An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235794
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : December 27, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 6, 2005
First Posted Date  ICMJE October 10, 2005
Last Update Posted Date December 27, 2007
Study Start Date  ICMJE January 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2007)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
This is an exploratory biomarker study. Outcome is measured by effect of temsirolimus containing the neoadjuvant CCI-779 on phosphorylation of mTOR pathway proteins. This is measured by comparing pre-post treatment tissue and blood samples.
Change History Complete list of historical versions of study NCT00235794 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2007)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2005)
Effect of temsirolimus on gene expression will be measured by comparing pre-and post treatment blood and tissue samples
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
Official Title  ICMJE 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
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 approximately 4 weeks (+/- 2 weeks) before prostatectomy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Prostatic Neoplasms
Intervention  ICMJE Drug: temsirolimus
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 8, 2007)
Original Enrollment  ICMJE
 (submitted: October 6, 2005)
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00235794
Other Study ID Numbers  ICMJE 3066A1-132
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP