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

Novartis

Status

Conditions: Metastatic Renal Cell Cancer

Treatments: Drug: Everolimus

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00655252

CRAD001L2401

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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