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

Metastatic Hormone Refractory Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636090
• Other study ID #: Pro00000346
• Secondary ID: CA123175R01-A2-0
• Status: Completed
• Phase: N/A
• First received: March 9, 2008
• Last updated: December 3, 2013
• Start date: January 2007
• Est. completion date: January 2010

Study information

• Verified date: December 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be enrolled in the clinical study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer at the time of enrollment onto this study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metastatic Hormone Refractory Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001.		pre-treatment, day 29, and monthly blood samples	No
Secondary	To determine by comparative genomic hybridation (CGH) loss of heterozygosity (LOH) patterns of the 10q23 locus (to assess PTEN status) and other sites of chromosomal alterations associated with pathologic response to mTOR inhibition.		pre-treatment, day 19, and monthly blood samples	No
Secondary	To identify expression profiles associated with AKT activation and RAD001 treatment effect.		pre-treatment, day 29, and monthly blood samples	No
Secondary	To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.		pre-treatment, day 29, and monthly blood samples	No