CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
RAD001 +2 moredrug
Likely dose
Prednisone 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00459186
NCT00459186Phase 2Completed
CompareCT.gov

A Phase I/II Study of RAD001 With Docetaxel in the Treatment of Metastatic, Androgen Independent Prostate Cancer

Dana-Farber Cancer Institute·interventional·Posted Apr 11, 2007·Updated May 16, 2016

In Brief

A Phase 2 clinical trial evaluating RAD001, Docetaxel, and 1 other intervention for Metastatic, Androgen Independent Prostate Cancer and Prostate Cancer. Completed, enrolled 19 participants across 5 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic, Androgen Independent Prostate Cancer, Prostate Cancer
CountriesUnited States
CollaboratorsNovartis, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Oregon Health and Science University

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2007
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 19.2 years ago

Interventions

RAD001drug

Daily for two weeks

Docetaxeldrug

Infusion once per cycle

Prednisonedrug

Prednisone 5 mg by mouth twice daily