Expired Study
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Durham, North Carolina 27710


Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

Pro00000346


NCT ID:

NCT00636090


Secondary ID:

CA123175


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

Official Name:Daniel J George, MD
Principal Investigator
Duke University

Study Dates

Start Date:January 2007
Completion Date:January 2010
Completion Type:Actual
Primary Completion Date:December 2009
Primary Completion Type:Actual
Verification Date:December 2013
Last Changed Date:December 3, 2013
First Received Date:March 9, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:To identify candidate plasma markers of glycolysis that reflect tumor AKT activity.
Time Frame:pre-treatment, day 29, and monthly blood samples
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To identify expression profiles associated with AKT activation and RAD001 treatment effect.
Time Frame:pre-treatment, day 29, and monthly blood samples
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type: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
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Department of Defense

Samples and Retentions

Sample Retention:Samples With DNA
Description: This study involves the retention of tissue sample from tumor biopsies as well as blood samples.
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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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