ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer

Inclusion Criteria:

- Adults (Age ≥ 18 years)

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Life expectancy of at least 12 weeks

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- Progressive disease in the setting of medical or surgical castration (i.e. CRPC)

- Documented metastatic disease

- Must have undergone bilateral orchiectomy (surgical castration) or be willing to
continue gonadotropin-releasing hormone (GnRH) analog or antagonist (medical
castration)

- Serum testosterone <50 ng/dL

- Receipt of prior line of second generation androgen inhibitor

- Demonstrate adequate organ function as defined below:

- Absolute Neutrophil Count (ANC) ≥ 1,000/μL

- Platelet Count ≥ 100,000/μL

- Hemoglobin (Hgb) ≥ 8 g/dL

- Serum creatinine ≤ 2 × upper limit of normal (ULN) OR

- Creatinine clearance (CrCl) ≥ 40 mL/min as estimated by the Cockcroft and Gault
formula1 in subjects with creatinine > 2 X ULN

- Bilirubin ≤ 1.5 × ULN unless evidence of Gilbert's disease in which case < 3 x
ULN

- Aspartate aminotransferase (AST) ≤ 2.5 × ULN without liver metastases; must be ≤
5 × ULN with liver metastases

- Alanine aminotransferase (ALT) ≤ 2.5 × ULN without liver metastases; must be ≤ 5
× ULN with liver metastases

Exclusion Criteria:

- Known symptomatic brain metastases (NOTE: patients with treated epidural disease are
allowed)

- Treatment with any of the following for prostate cancer within the indicated timeframe
prior to day 1 of treatment:

1. First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide)
within 4 weeks

2. 5 alpha reductase inhibitors, ketoconazole, estrogens (including
diethylstilbesterol [DES]), or progesterones within 2 weeks

3. Chemotherapy within 3 weeks

4. Biologic therapy within 4 weeks

5. Investigational therapy within 3 weeks (or within a time interval less than at
least 5 half-lives of the investigational agent [if known], whichever is longer).

6. Immunotherapy within 4 weeks

7. Prior radionuclide therapy within 4 weeks