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| Sponsors and Collaborators: |
Dana-Farber Cancer Institute 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: | 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 Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2010 (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 | |
| 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 |
| Study First Received: | February 28, 2008 |
| Last Updated: | January 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00630344 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
RAD001 bicalutamide androgen independent prostate cancer |
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Everolimus Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms |
Genital Diseases, Male Hormones Immunosuppressive Agents Androgen Antagonists Bicalutamide Prostatic Neoplasms Androgens |
|
Everolimus Immunologic Factors Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male |
Immunosuppressive Agents Hormones Pharmacologic Actions Androgen Antagonists Neoplasms Neoplasms by Site Therapeutic Uses Bicalutamide Prostatic Neoplasms Androgens |