Tesetaxel in Chemotherapy-naive Patients With Progressive, Castration-resistant Prostate Cancer

Key Inclusion Criteria: * At least 18 years of age * Histologically confirmed prostate cancer, currently with progressive disease * Evidence of metastatic disease * Castrate level of testosterone (\< 50 ng/dL) * Eastern Cooperative Oncology Group performance status 0 or 1 * Chemotherapy-naïve * Adequate bone marrow, hepatic, and renal function * Ability to swallow an oral solid-dosage form of medication Key Exclusion Criteria: * History or presence of brain metastasis or leptomeningeal disease * Operable cancer * Uncontrolled diarrhea * Uncontrolled nausea or vomiting * Known malabsorptive disorder * Currently active second malignancy other than non-melanoma skin cancers * Human immunodeficiency virus (HIV) infection based on history of positive serology * Significant medical disease other than cancer * Presence of neuropathy \> Grade 2 (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]; v4.0) * Need for other anticancer treatment * Need to continue any regularly-taken medication that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity * Less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the CYP3A pathway or P-glycoprotein activity * Less than 4 weeks since use of another investigational agent