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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Novartis Massachusetts General Hospital Beth Israel Deaconess Medical Center Oregon Health and Science University |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00459186 |
The purpose of this study is to evaluate the safety and optimal dose of RAD001 and docetaxel plus prednisone in men with hormone refractory, metastatic prostate cancer (Phase I).
Once an appropriate dose is reached, the purpose then will be to determine the response rate of docetaxel plus RAD001 (Phase II).
Condition | Intervention | Phase |
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Metastatic, Androgen Independent Prostate Cancer Prostate Cancer |
Drug: RAD001 Drug: Docetaxel |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Oregon | |
Oregon Health Science University | |
Portland, Oregon, United States |
Principal Investigator: | Mary Ellen Taplin, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Mary-Ellen Taplin, MD ) |
Study ID Numbers: | 05-184 |
Study First Received: | January 23, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00459186 History of Changes |
Health Authority: | United States: Food and Drug Administration |
prostate cancer RAD001 mTOR inhibition docetaxel |
Everolimus Docetaxel Immunologic Factors Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Immunosuppressive Agents Prostatic Neoplasms Androgens |
Everolimus Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male |
Immunosuppressive Agents Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |