Status:
NO_LONGER_AVAILABLE
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Metastatic Renal Cell Cancer
Eligibility:
All Genders
18+ years
Brief Summary
This expanded access study is designed to provide RAD001 to patients with MRCC who are without satisfactory treatment alternatives, until RAD001 becomes commercially available.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ≥ 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00655252
Last Update
August 19 2011
Active Locations (84)
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1
Highlands oncology Group, PA
Springdale, Arkansas, United States, 72764
2
University of Colorado Health Sciences Center/Anschutz Pavillion
Aurora, Colorado, United States, 12801
3
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
4
MD Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806