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

Trial ID or NCT#

NCT01450683

Status

not recruiting iconNOT RECRUITING

Purpose

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).

Official Title

A Phase 2 Study of Itraconazole in Castrate-resistant Prostate Cancer Post-chemotherapy

Eligibility Criteria

Ages Eligible for Study: Older than 18
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. EXCLUSION CRITERIA
  3. * 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.
Exclusion Criteria:
  1. * 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.
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Investigator(s)

Sandhya Sandy Srinivas
Sandhya Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

ccto-office@stanford.edu
650-498-7061

View on ClinicalTrials.gov