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

Stopped early · Phase 2

Conditions studied: Prostate Cancer, Prostatic Neoplasms, Castrate-resistant Prostate Cancer (CRPC), Androgen-insensitive Prostate Cancer, Hormone-refractory Prostate Cancer, Metastatic Disease

In brief

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).

Key facts

Study ID

NCT01450683

Run by

Stanford University

People needed

4

Starts

2010-09-01

Expected to finish

2011-04-01

Last updated by the study team

2017-04-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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