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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborators: |
Beth Israel Deaconess Medical Center Novartis Pharmaceuticals |
| 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer |
| Estimated Enrollment: | 38 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 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| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02115 | |
| Study Chair: | Mary-Ellen Taplin, MD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | Mary Ellen Taplin, MD, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00630344 History of Changes |
| Other Study ID Numbers: | 07-316 |
| Study First Received: | February 28, 2008 |
| Last Updated: | June 6, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
RAD001 bicalutamide androgen independent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Sirolimus Everolimus Bicalutamide Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Anti-Bacterial Agents Androgen Antagonists Hormone Antagonists |