- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00235794
An Open Label Exploratory Study in Newly Diagnosed Prostate Cancer Patients
December 18, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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
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
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Houston, Texas, United States, 77030
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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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.
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
October 6, 2005
First Submitted That Met QC Criteria
October 6, 2005
First Posted (Estimate)
October 10, 2005
Study Record Updates
Last Update Posted (Estimate)
December 27, 2007
Last Update Submitted That Met QC Criteria
December 18, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 3066A1-132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Technische Universität DresdenRecruitingOligometastatic Disease | Prostatic Cancer, Castration-ResistantGermany
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Yinghao SunNot yet recruitingCastration-Resistant Prostatic Cancer
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Janssen Research & Development, LLCCompletedCastration-Resistant Prostatic NeoplasmsCanada, Belgium, United States, Spain, Netherlands, Italy, Russian Federation
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Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
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University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
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Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
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Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterActive, not recruitingProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Cancer Recurrent | Prostatic Cancer MetastaticUnited States
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AVEO Pharmaceuticals, Inc.Completed
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Dana-Farber Cancer InstituteWyeth is now a wholly owned subsidiary of Pfizer; Millennium Pharmaceuticals...CompletedMultiple MyelomaUnited States
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Mathias Witzens-HarigCharite University, Berlin, Germany; Ludwig-Maximilians - University of Munich and other collaboratorsUnknownDiffuse Large B-Cell LymphomaGermany
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Georgetown UniversityWyeth is now a wholly owned subsidiary of PfizerCompletedAdvanced Solid TumorsUnited States
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Goethe UniversityCompletedAcute Myeloblastic LeukemiaGermany
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Wyeth is now a wholly owned subsidiary of PfizerPfizerCompletedBreast Neoplasms
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Loyola UniversityWyeth is now a wholly owned subsidiary of PfizerTerminated