Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer
NCT01020305
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Descriptive Information | |||||||
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Brief Title ICMJE | Temsirolimus to Reverse Androgen Insensitivity for Castration-resistant Prostate Cancer | ||||||
Official Title ICMJE | Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer | ||||||
Brief Summary | This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC). | ||||||
Detailed Description | Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC, there remains unmet medical need. New therapies that extend survival of patients beyond that provided by chemotherapy are needed. The mechanisms of tumor progression to castration-resistance are unclear, but preclinical studies suggest that functional loss of the tumor suppressor gene PTEN and subsequent up-regulation of Akt, which is upstream of mTOR, may be involved in prostate cancer progression and metastasis. Based on these observations, it is hypothesized that mTOR inhibitor temsirolimus may prolong hormone sensitivity and delay disease progression in castration-resistant prostate cancer patients before antiandrogen withdrawal. This study will assess efficacy on the basis of serum levels of PSA, an established surrogate endpoint for efficacy in prostate cancer. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Temsirolimus + Bicalutamide
Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks Casodex (bicalutamide) administered 50 mg/day orally (PO) Interventions:
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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 | Terminated | ||||||
Actual Enrollment ICMJE | 5 | ||||||
Original Estimated Enrollment ICMJE | 40 | ||||||
Actual Study Completion Date ICMJE | April 2012 | ||||||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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Sex/Gender ICMJE |
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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 | NCT01020305 | ||||||
Other Study ID Numbers ICMJE | IRB-17242 SU-09292009-4080 ( Other Identifier: Stanford University ) PROS0028 ( Other Identifier: OnCore ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Sandy Srinivas, Stanford University | ||||||
Study Sponsor ICMJE | Sandy Srinivas | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Stanford University | ||||||
Verification Date | October 2014 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |