drugset / Trial / NCT00459186
The Use of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer
Phase 1/2
Completed
19 enrolled
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center · collabMassachusetts General Hospital · collabNovartis · collabOregon Health and Science University · collab
NaSingle-groupOpen-labelTreatment
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).
Timeline
- Start
- 2005-11
- Primary completion
- 2012-12
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 60 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Everolimus | Small molecule | 5 mg | — |
| Subject | Everolimus | Small molecule | 10 mg | — |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |