Trial Search Results
Study of Itraconazole in Castrate-resistant Prostate Cancer (CRPC) 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).
Stanford is currently not accepting patients for this trial.
- Drug: Itraconazole
- 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
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study