RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Study to Compare the Safety and Efficacy of RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed on VEGF Receptor Tyrosine Kinase Inhibitor

To assess whether daily treatment with RAD001 could slow the growth and spread of metastatic carcinoma of the kidney. The safety of RAD001 was also to be studied in this trial.

Inclusion Criteria:

• Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable).
• The date of progression on sunitinib and/or sorafenib must be within 6 months.
• Patients may have received one or both agents
• Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors (i.e., bevacizumab) are permitted.
• Prior vaccine therapy in the adjuvant setting is permitted.
• Patients with at least one measurable lesion at baseline as per the Response evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
• Patients with a Karnofsky Performance Status ≥70%.
• Adequate bone marrow, liver and renal function.
• Patients with a life expectancy ≥ 3 months.
• Women of childbearing potential must have had a negative serum or urine pregnancy test 48 hours prior to the administration of the first study treatment.
• Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

• Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have received these within 4 weeks of study entry
• Patients who have previously received mTOR inhibitors.
• Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus) or to its excipients.
• Patients with untreated CNS metastases or who are neurologically unstable despite treatment of the CNS metastases. (Patients with treated CNS metastases, who are neurologically stable off of corticosteroids, are eligible to enter study).
• Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
• Patients with a known history of HIV seropositivity.
• Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
• Patients who have any severe and/or uncontrolled medical conditions
• Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
• Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
• Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to randomization
• Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply.