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Sponsors and Collaborators: |
University of Chicago Novartis |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00529802 |
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 |
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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 |
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A: Experimental
high uptake of FDG-PET
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Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
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B: Experimental
low uptake of FDG-PET
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Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Walter Stadler, MD | University of Chicago |
Responsible Party: | Novartis ( Tina Grasso ) |
Study ID Numbers: | 15599B |
Study First Received: | September 12, 2007 |
Last Updated: | June 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00529802 |
Health Authority: | United States: Food and Drug Administration |
metastatic renal cell carcinoma cancer |
Everolimus Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |