Prostate Cancer Clinical Trial
Official title:
A Phase 2 Study of Itraconazole in Castrate-resistant Prostate Cancer Post-chemotherapy
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).
Status | Terminated |
Enrollment | 4 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Serum PSA | Number of subjects with > 50% drop in serum PSA as compared to baseline, at 12 weeks and confirmed at 15 weeks | 12 weeks treatment, with primary outcome assessed at 15 weeks | No |
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