Expanded Access Study of RAD001 in Metastatic Renal Cell Cancer Patients Who Are Intolerant of or Who Have Failed Despite Prior Vascular Endothelial Growth Factor Therapy

NO_LONGER_AVAILABLE

Conditions studied: Metastatic Renal Cell Cancer

In brief

This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.

Key facts

Study ID

NCT00655252

Run by

Novartis Pharmaceuticals

Last updated by the study team

2011-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old; metastatic renal cancer, intolerant of or failed sunitinib and/or sorafenib
• Adequate bone marrow function, liver function, renal function
• Adequate birth control

You may not qualify if…

• Previously received RAD001 or other mTOR inhibitors, known hypersensitivity to rapamycin, chronic systemic treatment with corticosteroids or immunosuppressive agents (prednisone ≤ 20 mg/day for adrenal insufficiency OK
• Topical or inhaled steroids OK)
• Active bleeding
• Uncontrolled angina, CHF, heart attack ≤ 6 months, uncontrolled diabetes
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Colorado Health Sciences Center/Anschutz Pavillion — Aurora, Colorado, United States
• Cancer Centers of Florida, P.A. — Ocoee, Florida, United States
• MD Anderson Cancer Center - Orlando — Orlando, Florida, United States
• Indiana University Cancer center — Indianapolis, Indiana, United States
• The Cancer Institute, St. Joseph Medical Center — Towson, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Heartland Hematology-Oncology Associates, Inc. — Kansas City, Missouri, United States
• Washington University/Siteman Cancer Center — St Louis, Missouri, United States
• Blumenthal Cancer Center/Carolinas Medical Center — Charlotte, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Cliveland Clinic Foundation — Cleveland, Ohio, United States
• Cleo Craig Memorial Cancer & Research Clinic — Lawton, Oklahoma, United States
• Cancer centers of the Carolinas — Greenville, South Carolina, United States
• Novartis Investigative Site — Malvern, Australia
• Novartis Investigative Site — Graz, Austria
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Salzburg, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Brussels, Belgium
• Moncton Hospital — Moncton, New Brunswick, Canada
• QE ll Health Sciences Centre — Halifax, Nova Scotia, Canada
• Royal Victoria Hospital — Barrie, Ontario, Canada
• Lakeridhe Health Corp - Oshawa — Oshawa, Ontario, Canada
• Highlands oncology Group, PA — Springdale, Arkansas, United States

Full record on ClinicalTrials.gov

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