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Sponsors and Collaborators: |
Duke University Novartis |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00629525 |
The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer.
Condition | Intervention | Phase |
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Hormone Refractory Prostate Cancer |
Drug: RAD001 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
RAD001
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Drug: RAD001
RAD001 at a dose of 10 mg PO daily
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This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Evidence of disease progression on ADT as evidenced by:
Exclusion Criteria:
Contact: Karla Morris, RN | 919-668-8375 | karla.morris@duke.edu |
United States, North Carolina | |
Duke University MEdical Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Principal Investigator: Daniel J George, MD |
Principal Investigator: | Daniel J George, MD | Duke University Health System |
Responsible Party: | Duke University Medical Center ( Daniel J George, MD ) |
Study ID Numbers: | 7521 |
Study First Received: | February 27, 2008 |
Last Updated: | February 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00629525 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Everolimus Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Immunologic Factors |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |