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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Novartis |
| Information provided by: | Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00630344 |
Purpose
The goal of this clinical trial is to learn if the study drug RAD001 in combination with Bicalutamide can slow the growth of prostate cancer. The safety of RAD001 given together with Bicalutamide will also be studied. RAD001 has been shown to kill prostate cancer cells. In addition, several hundred kidney and heart transplant patients have been treated with the same main ingredient as in RAD001 for many years.
| Condition | Intervention | Phase |
|
Prostate Cancer |
Drug: RAD001 Drug: Bicalutamide |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| ChemIDplus related topics: | Everolimus Bicalutamide |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer |
| Estimated Enrollment: | 38 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mary-Ellen Taplin, MD | 617-632-5092 | |
| Contact: Geoffrey Buckle | 617-632-5287 |
| United States, Massachusetts | |||||
| Dana-Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Mary-Ellen Taplin, MD | |||||
| Beth Israel Deaconess Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Principal Investigator: Glenn Bubley, MD | |||||
| Dana-Farber Cancer Institute |
| Beth Israel Deaconess Medical Center |
| Novartis |
| Study Chair: | Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Dana-Farber Cancer Institute ( Mary Ellen Taplin, MD ) |
| Study ID Numbers: | 07-316 |
| First Received: | February 28, 2008 |
| Last Updated: | February 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00630344 |
| Health Authority: | United States: Food and Drug Administration |
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