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
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: 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 Pharmaceuticals
• Treatments: 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