- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00887458
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer
This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) for the treatment of various fungal infections such as fingernail/toenail infections and other more serious fungal infections. The word "investigational" means that itraconazole is not approved for use in people with cancer. However, the FDA is allowing the use of itraconazole in this research study. Itraconazole has been shown to have activity against cancer (including prostate cancer) in the laboratory, but has not been tested against cancer in humans.
The purpose of this study is to find out:
- If itraconazole is safe when given at two different doses
- How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer
- Whether itraconazole can delay further prostate cancer growth and spread
- How itraconazole affects other markers of prostate cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Itraconazole is an oral, generic, and commercially available antifungal drug with a long safety record when used at doses ranging from 200 to 600 mg daily.
Itraconazole has been shown in cellular and animal models to be a potent angiogenesis inhibitor as well as a Hedgehog pathway antagonist; both pathways are considered important in prostate cancer. Itraconazole has not previously been tested as an antineoplastic agent, but given its well-established safety profile, the gap between further preclinical studies and human clinical trials can be narrowed to accelerate development of this agent as a putative anticancer drug. The investigators hypothesize that itraconazole will prevent PSA progression in a significant proportion of men with metastatic CRPC and that it will have an acceptable safety profile at both doses. Itraconazole may ultimately delay the need for chemotherapy in these men.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins Hospital
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Center
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Presence of distant metastases on bone scan, CT scan, or MRI scan.
- Progression after androgen deprivation (and anti-androgen withdrawal).
- Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
- Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
- Age > 18 years.
- ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
- Life expectancy > 6 months.
- Adequate kidney, liver, and bone marrow function.
- Willingness to sign informed consent and adhere to study requirements.
Exclusion Criteria:
- Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
- Previous chemotherapy for metastatic prostate cancer.
- Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
- Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
- History of malabsorption syndrome (may affect itraconazole absorption).
- Allergic reactions to itraconazole or similar compounds.
- Concurrent use of drugs that interact with the CYP3A4 system (caution only).
- Presence of known brain metastases.
- Prior malignancy in the last 3 years, with some exceptions.
- Uncontrolled major infectious, cardiac, or pulmonary illnesses.
- Prolonged corrected QT interval (> 450 msec) on electrocardiography.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Low Dose
Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
|
Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
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ACTIVE_COMPARATOR: High Dose
Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
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Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy With One of Two Dose-levels of Itraconazole: 200 mg or 600 mg Daily.
Time Frame: Up to 24 weeks
|
To Determine the Proportion of Patients With Metastatic CRPC Who do Not Have Prostate Specific Antigen (PSA) Progression After 24 Weeks of Therapy.
"PSA progression" is defined as a 25% increase in PSA over baseline [or nadir (lowest)] and an increase in absolute PSA level by at least 2 ng/mL, both confirmed by a second value at least 4 weeks later.
|
Up to 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.
Time Frame: Baseline and approximately 2 years from open enrollment
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Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.
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Baseline and approximately 2 years from open enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael A Carducci, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Itraconazole
- Hydroxyitraconazole
Other Study ID Numbers
- J0932
- JHMI-IRB number: NA_00027099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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