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| ID | Type | Description | Link |
|---|---|---|---|
| JHMI-IRB number: NA_00027099 |
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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Active Comparator | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) |
|
| High Dose | Active Comparator | Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole 200 mg | Drug | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) |
| |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline. | Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline. | Baseline and approximately 2 years from open enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Carducci, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21231 | United States | ||
| University of Michigan Comprehensive Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) |
| FG001 | High Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Itraconazole 300mg |
| Drug |
Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) |
|
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) |
| BG001 | High Dose | Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Based on how many participants were evaluable for the study primary endpoint | Posted | Number | 95% Confidence Interval | percent of patients | Up to 24 weeks |
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| Secondary | To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline. | Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline. | One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression. | Posted | Number | 95% Confidence Interval | percentage | Baseline and approximately 2 years from open enrollment |
|
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low Dose | Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose) | 1 | 17 | 14 | 17 | ||
| EG001 | High Dose | Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose) | 0 | 29 | 14 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Carducci | Johns Hopkins University | 410-614-3977 | carducci@jhmi.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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