Ignite Creation Date:
2024-05-05 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00636090
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2008-03-09
Brief Title:
Molecular Genetic and Genomic Assessments From Patients Treated With RAD001
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Molecular Genetic and Genomic Assessments of MTOR Inhibition in Metastatic Hormone-Refractory Prostate Cancer Tissue From Patients Treated With RAD001
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA123175 | None | None | None |
| R01-A2-022207 | None | None | None |