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

NCT01450683 | Terminated Phase 2 Results DMC

• 3 other identifiers: IRB-19413SU-12032010-7271PROS0037
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer; Prostatic Neoplasms; Castrate-resistant Prostate Cancer (CRPC); Androgen-insensitive Prostate Cancer; Hormone-refractory Prostate Cancer; Metastatic Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Itraconazole

EXPERIMENTAL

600 mg/day oral (PO)

Drug: Itraconazole

Interventions

Itraconazole DRUG

600 mg/day oral (PO) IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-\[4-(4-{\[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl\]methoxy}phenyl)piperazin-1-yl\]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one

Also known as: Sporanox, R51211

Itraconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm Metastasis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Associate Professor of Medicine (Oncology)
• Organization: Stanford University Medical Center

sandysri@stanford.edu

650-725-2078

Study Officials

• Dr. Sandy Srinivas

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 12, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 11, 2017
• Results First Posted: September 8, 2014

Record last verified: 2017-03

Locations

US (1)