A Phase II Study of Single-agent Tesetaxel in Chemotherapy-naive Patients Who Have 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