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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00636090
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : December 4, 2013
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date March 9, 2008
First Posted Date March 14, 2008
Last Update Posted Date December 4, 2013
Study Start Date January 2007
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 13, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00636090 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 13, 2008)
  • 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 ]
  • To identify expression profiles associated with AKT activation and RAD001 treatment effect. [ Time Frame: pre-treatment, day 29, and monthly blood samples ]
  • To identify candidate plasma markers of glycolysis that reflect tumor AKT activity. [ Time Frame: pre-treatment, day 29, and monthly blood samples ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Molecular, Genetic, and Genomic Assessments From Patients Treated With RAD001
Official Title Molecular, Genetic, and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
Brief 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
This study involves the retention of tissue sample from tumor biopsies as well as blood samples.
Sampling Method Non-Probability Sample
Study Population Adult men enrolled in the study entitled: A Single Arm, Phase II Study of RAD001 in Patients with Metastatic, Hormone-Refractory Prostate Cancer.
Condition Metastatic Hormone Refractory Prostate Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 13, 2012)
35
Original Estimated Enrollment
 (submitted: March 13, 2008)
60
Actual Study Completion Date January 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00636090
Other Study ID Numbers Pro00000346
CA123175
R01-A2-022207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators United States Department of Defense
Investigators
Principal Investigator: Daniel J George, MD Duke University
PRS Account Duke University
Verification Date December 2013