Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

Exclusion Criteria

• •Prior treatment with cabozantinib.
• •Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks.
• •Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization.
• •Known brain metastases or cranial epidural disease.
• •Requires concomitant treatment, in therapeutic doses, with anticoagulants.
• •Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort).
• •Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery.
• •Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months.
• •Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel.
• •QTcF \> 500 ms within 7 days of randomization.
• •Unable to swallow capsules or tablets.
• •Previously-identified allergy or hypersensitivity to components of the study treatment formulations.
• •Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.