Advanced Renal Cell Carcinoma Therapy Study
To provide study drug plus everolimus or everolimus to patients with advanced renal cell carcinoma and to collect additional data on treatment safety.
In order to participate you must meet the following criteria:
- Have received at least one course of therapy with a VEGFR-targeting tyrosine kinase inhibitor (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib) and progressed within 6 months of planned first dose of study treatment.
- Have tissue blocks or tissue sections from initial diagnosis or upon diagnosis of advanced metastatic disease will be available for submission to the central laboratory within approximately 4 weeks after initiation of study treatment.
- Have an ECOG performance status of 0, 1 or 2.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (e.g., temsirolimus).
- Have had myocardial infarction within the previous 6 months before planned first dose of study drug.
- Have chronic treatment with corticosteroids or other immunosuppressive agents.
- Have had radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before planned first dose of study drug. Systemic treatment with radionuclides within 6 weeks before planned first dose of study drug. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
This is a partial list of inclusion and exclusion criteria.