NCT00636090

Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001

Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at the genetic changes that RAD001 causes in prostate cancer cells and how those changes relate to patients' response to RAD001 treatment.

Detailed description

This correlative science study will be a minimum risk assessment of tumor and plasma samples collected as part of a Phase II clinical trial of RAD001 in patients with HRPC. Prior to enrollment or at the time of signing consent in the Phase II trial, patients will be approached to participate in the correlative science study. Patients who agree to participate will be assigned a separate study number which will be used to identify their molecular, genetic, genomic and biomarker assessments using the tumor and plasma samples. Clinical outcome results from the accompanying Phase II trial will be used for correlative assessments in this study, however, results from this correlative science study will be kept separate from the assessments and reporting of the clinical trial.

Conditions

• Metastatic Hormone Refractory Prostate Cancer

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2008-03-14
• Last updated: 2013-12-04

Locations

1 site across 1 country: United States