The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
NCT00459186 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2016-05-16
Summary
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).
Conditions
- Metastatic, Androgen Independent Prostate Cancer
- Prostate Cancer
Interventions
- DRUG
-
RAD001
Daily for two weeks
- DRUG
-
Infusion once per cycle
- DRUG
-
Prednisone 5 mg by mouth twice daily
Sponsors & Collaborators
- collaborator INDUSTRY
-
Massachusetts General Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Oregon Health and Science University
collaborator OTHER - lead OTHER
Principal Investigators
-
Mary Ellen Taplin, MD · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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