Overview
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
Status:
No longer available
No longer available
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
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.Details
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Endothelial Growth Factors
Everolimus
Mitogens
Criteria
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