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| Study 1 of 22 for search of: | predictive marker pet |
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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
Novartis |
| Information provided by: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00529802 |
Purpose
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Carcinoma, Renal Cell |
Drug: RAD001 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
high uptake of FDG-PET
|
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
|
|
B: Experimental
low uptake of FDG-PET
|
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Walter Stadler, MD | 773-702-4150 | wstadler@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Beth Manchen, RN 773-702-4135 emanchen@medicine.bsd.uchicago.edu | |
| Contact: Dale Rush 773-834-0669 drush@medicine.bsd.uchicago.edu | |
| Oncology/Hematology Associates | Recruiting |
| Peoria, Illinois, United States, 61615 | |
| Contact: Sachdev Thomas, MD | |
| United States, Massachusetts | |
| Beth Israel Deaconess Med Ctr | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: David McDormatt, MD | |
| United States, Missouri | |
| Washington University | Recruiting |
| St Louis, Missouri, United States, 63110 | |
| Contact: Joel Picus, MD | |
| United States, North Carolina | |
| The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Kimryn Rathmell, MD, PhD | |
| Principal Investigator: | Walter Stadler, MD | University of Chicago |
More Information
| Responsible Party: | The University of Chicago ( Walter Stadler, M.D. ) |
| Study ID Numbers: | 15599B |
| Study First Received: | September 12, 2007 |
| Last Updated: | April 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00529802 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
metastatic renal cell carcinoma cancer |
|
Everolimus Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Immunosuppressive Agents Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial |