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

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluates if itraconazole causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

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.