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| Descriptive Information Fields | |||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | Cohort, Prospective | ||||
| 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 ] | ||||
| 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 ] [ 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 ] |
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| Condition † | Metastatic Hormone Refractory Prostate Cancer | ||||
| Intervention † | |||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 60 | ||||
| Start Date † | January 2007 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00636090 | ||||
| Organization ID | DUMC-0346 | ||||
| Secondary IDs †† | CA123175, R01-A2-022207 | ||||
| Study Sponsor † | Duke University | ||||
| Collaborators †† | Department of Defense | ||||
| Investigators † |
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| Information Provided By | Duke University | ||||
| Verification Date | March 2008 | ||||
| First Received Date † | March 9, 2008 | ||||
| Last Updated Date | March 13, 2008 | ||||
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