A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma

Select Inclusion Criteria:

• Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
• Measurable disease as determined by the investigator.
• Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
• Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
• Adequate organ and marrow function.
• Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
• Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

• Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
• Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
• Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
• Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
• Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
• Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
• Chronic treatment with corticosteroids or other immunosuppressive agents.
• Serious illness other than cancer.
• Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
• Pregnant or lactating females.
• Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.