Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy

INCLUSION CRITERIA

   - Male aged ≥ 18 years

   - Life expectancy ≥ 6 months

   - Histologically- or cytologically-confirmed adenocarcinoma of the prostate

   - Metastatic disease or prior history of metastases, as documented by positive bone scan
   or metastatic lesions on CT or MRI

   - Prostate cancer progression, as documented by PSA according to PCWG2 or radiographic
   progression according to RECIST criteria version 1.1

   - Progression must have been during or after docetaxel based chemotherapy.

   - Surgically or medically castrated, with testosterone levels of < 50 ng/dL (< 2.0 nM).
   If the patient is currently being treated with LHRH agonists (patient who have not
   undergone an orchiectomy), this therapy must have been initiated at least 4 weeks
   prior to Cycle 1 Day 1 and treatment must be continued throughout the study.

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2

   - Hemoglobin ≥ 10.0 g/dL

   - Platelet count ≥100,000 microliters

   - Serum creatinine ≤ 2, OR a calculated creatinine clearance ≥ 40 mL/min

   - Serum bilirubin < 1.5 x ULN (except for patients Gilbert's disease)

   - AST or ALT < 2.5 x ULN

   - Able to swallow the study drug whole as a tablet

   - Willing and able to provide written informed consent

EXCLUSION CRITERIA

   - Known brain metastasis

   - Radiation therapy within 4 weeks of Cycle 1, Day 1

   - Prior systemic treatment with an azole drug (eg, fluconazole, ketoconazole) within 4
   weeks of Cycle 1, Day 1

   - Prior flutamide (Eulexin) treatment within 4 weeks of Cycle 1, Day 1 (patients whose
   PSA did not decline for ≥ 3 months months in response to antiandrogen given as a 2nd
   line or later intervention will require only a 2-week washout prior to Cycle 1,Day 1)

   - Prior Bicalutamide (Casodex), nilutamide (Nilandron) treatment within 6 weeks of Cycle
   1 Day 1 (patients whose PSA did not decline for ≥ 3 months in response to antiandrogen
   given as a 2nd line or later intervention will require only a 2-week washout prior to
   Cycle 1 Day 1)

   - Known active or symptomatic viral hepatitis or chronic liver disease

   - Clinically significant heart disease as evidenced by myocardial infarction or arterial
   thrombotic events in the past 6 months; severe or unstable angina

   - Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of
   recurrence within 24 months

   - Administration of an investigational therapeutic within 30 days of Cycle 1, Day 1

   - Any condition which, in the opinion of the investigator, would preclude the patient's
   participation in this trial.

   - No more than 3 prior chemotherapy regimens.