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Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001
This study is currently recruiting participants.
Study NCT00636090   Information provided by Duke University
First Received: March 9, 2008   Last Updated: April 23, 2009   History of Changes

March 9, 2008
April 23, 2009
January 2007
July 2009   (final data collection date for primary outcome measure)
Functional extent of mTOR inhibition in the phosphorylation status of S6K and CA IX protein in prostate tumors from patients treated with RAD001. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00636090 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: pre-treatment, day 19, and monthly blood samples ] [ Designated as safety issue: No ]
  • To identify expression profiles associated with AKT activation and RAD001 treatment effect. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]
  • To identify candidate plasma markers of glycolysis that reflect tumor AKT activity. [ Time Frame: pre-treatment, day 29, and monthly blood samples ] [ Designated as safety issue: No ]
Same as current
 
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

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.

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.

 
Observational
Cohort, Prospective
Metastatic Hormone Refractory Prostate Cancer
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
December 2009
July 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact: Karla Morris, BSN 919-668-8375 karla.morris@mc.duke.edu
United States
 
NCT00636090
Daniel George, MD, Duke University Medical Center
DUMC-0346, CA123175, R01-A2-022207
Duke University
Department of Defense
Principal Investigator: Daniel J George, MD Duke University
Duke University
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP