An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
NCT00235794
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Homewood, Alabama
- Anchorage, Alaska
- Tucson, Arizona
- Highland, California
- San Diego, California
- Denver, Colorado
- Middlebury, Connecticut
- Melrose Park, Illinois
- Springfield, Illinois
- Jeffersonville, Indiana
- West Des Moines, Iowa
- Kansas City, Kansas
- Baltimore, Maryland
- Bethesda, Maryland
- Ann Arbor, Michigan
- Grand Rapids, Michigan
- Minneapolis, Minnesota
- Billings, Montana
- Lawrenceville, New Jersey
- Poughkeepsie, New York
- Rochester, New York
- Staten Island, New York
- Chapel Hill, North Carolina
- Greensboro, North Carolina
- Cincinnati, Ohio
- Columbus, Ohio
- Bala-Cynwyd, Pennsylvania
- Lancaster, Pennsylvania
- Myrtle Beach, South Carolina
- Nashville, Tennessee
- Houston, Texas
- San Antonio, Texas
- Virginia Beach, Virginia
- Burien, Washington
- Wenatchee, Washington
- Milwaukee, Wisconsin
- Brussels,
- Gent,
- Kortrijk,
- Leuven,
- Liege,
- Turnhout,
- Calgary, Alberta
- Abbotsford, British Columbia
- Kingston, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Granby, Quebec
- Montreal, Quebec
- Aalborg,
- Aarhus,
- Copenhagen,
- Herlev,
- Creteil,
- Lille,
- Lyon Cedex 3,
- Paris Cedex 10,
- Poitiers Cedex,
- Rennes Cedex,
- Rouen,
- Suresnes Cedex,
- Nuertingen, Baden-Wuerttemberg
- Aachen,
- Bergisch Gladbach,
- Bonn,
- Bonn,
- Bonn,
- Hamburg,
- Hannover,
- Reutlingen,
- Waldshut-Tiengen,
- Wuppertal,
- Bucharest, RO
- Bucharest, RO
- Bucharest,
- Bristol, UK
- London, UK
- London, UK
- Cardiff, Wales
- Belfast,
- Cambridge,
- Glasgow,
- Leicher,
- London,
- Manchester,
- Merseyside,
- Northwood, Middlesex,
- Preston,
- Harvey, Illinois
- Tinley Park, Illinois
- Hobart, Indiana
- Munster, Indiana
- Durham, North Carolina
- Portland, Oregon
- Portland, Oregon
- Myrtle Beach, South Carolina
- Clarksville, Tennessee
- Franklin, Tennessee
- Gallarin, Tennessee
- Hermitage, Tennessee
- Lebanon, Tennessee
- Murfreesboro, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Nashville, Tennessee
- Smithville, Tennessee
- Smyrna, Tennessee
- Tullahoma, Tennessee
- Dallas, Texas
- Houston, Texas
- Madison, Wisconsin
- Houston, Texas
- Morristown, New Jersey
- Whippany, New Jersey
- Tucson, Arizona
- Tucson, Arizona
- Golden, Colorado
- New Haven, Connecticut
- Bethesda, Maryland
- Bethesda, Maryland
- Creve Coeur, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Saint Louis, Missouri
- Omaha, Nebraska
- Las Vegas, Nevada
- Morristown, New Jersey
- Morristown, New Jersey
- Rockaway, New Jersey
- Lake Success, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- Durham, North Carolina
- Durham, North Carolina
- Pittsburgh, Pennsylvania
- Seattle, Washington
- Seattle, Washington
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 ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 50 | |||
Original Enrollment ICMJE | 10 | |||
Actual Study Completion Date ICMJE | September 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |