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Sponsors and Collaborators: |
The Methodist Hospital System Novartis |
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Information provided by: | The Methodist Hospital System |
ClinicalTrials.gov Identifier: | NCT00446368 |
Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.
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: | Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer |
Estimated Enrollment: | 80 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: RAD001
Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
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Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility criteria are met and they agree to participate. The participant will take RAD001 (Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and 21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests will be done.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The Methodist Hospital Research Institute | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Robert J Amato, DO | The Methodist Hospital Research Institute |
Responsible Party: | The Methodist Hospital Physician Organizaton ( Robert J. Amato, DO ) |
Study ID Numbers: | RCC-RAD-01, 03-0183-05 |
Study First Received: | March 9, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00446368 |
Health Authority: | United States: Food and Drug Administration |
metastatic kidney cancer metastatic renal cell 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 |