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