NCT00629525

RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

A Single Arm, Two Center, Phase II Study of RAD001 in Patients With Metastatic, Hormone-Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Daniel George, MD · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the biochemical response rate (PSA) to single agent RAD001 in patients with metastatic hormone-refractory prostate cancer (HRPC).

Detailed description

This is a single center, Phase II study of RAD001 in men with HRPC. The study design is a straight forward, two-stage design with tumor biopsies scheduled at screening and again at 4 weeks. FLT-PET scans are performed at screening and again at day 28, following initiation of treatment in the first 10 patients. Patients are assessed for adverse events every two weeks for the first month and monthly thereafter. Patients are assessed for response by PSA every 4 weeks and when applicable, for objective response every 2 months. If 4 or more responses are seen in the first 39 patients then the study will expand to 60 patients.

Conditions

• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	RAD001	RAD001 at a dose of 10 mg PO daily

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-03-06
• Last updated: 2015-03-03
• Results posted: 2013-02-07

Locations

1 site across 1 country: United States