Status:
TERMINATED
Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) Post-chemotherapy
Lead Sponsor:
Stanford University
Conditions:
Prostate Cancer
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
Castration-resistant prostate cancer (CRPC) is also known as "androgen-insensitive" or "hormone-refractory" prostate cancer. While numerous therapies impact biochemical response in the setting of CRPC...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01450683
Start Date
September 1 2010
End Date
April 1 2011
Last Update
April 11 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305