An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00235794

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

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: CCI 779

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacodynamics Study
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

Further study details as provided by Wyeth:

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009