Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-01 @ 11:35 AM
Study NCT ID:
NCT00887458
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2009-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'carducci@jhmi.edu', 'phone': '410-614-3977', 'title': 'Dr. Michael Carducci', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '4 years', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)\n\nItraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)', 'otherNumAtRisk': 17, 'otherNumAffected': 14, 'seriousNumAtRisk': 17, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'High Dose', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)\n\nItraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)', 'otherNumAtRisk': 29, 'otherNumAffected': 14, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '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.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose Itraconazole', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)\n\nItraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)'}, {'id': 'OG001', 'title': 'High Dose Itraconazole', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)\n\nItraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '36.4'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '68.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': '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.', 'unitOfMeasure': 'percent of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Based on how many participants were evaluable for the study primary endpoint'}, {'type': 'SECONDARY', 'title': 'To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)\n\nItraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)'}, {'id': 'OG001', 'title': 'High Dose', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)\n\nItraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '19.5'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '32.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and approximately 2 years from open enrollment', 'description': 'Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject in the high dose arm was not evaluable on account of subject discontinuing study drug during cycle 1 due to clinical progression.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)\n\nItraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)'}, {'id': 'FG001', 'title': 'High Dose', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)\n\nItraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)\n\nItraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)'}, {'id': 'BG001', 'title': 'High Dose', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)\n\nItraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000', 'lowerLimit': '60', 'upperLimit': '81'}, {'value': '71', 'groupId': 'BG001', 'lowerLimit': '52', 'upperLimit': '89'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '52', 'upperLimit': '89'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2009-04-23', 'resultsFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2009-04-23', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-12-11', 'studyFirstPostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Up to 24 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To Determine the Proportion of Men With ≥ 50% PSA Reduction From Baseline.', 'timeFrame': 'Baseline and approximately 2 years from open enrollment', 'description': 'Will be reported as the percentage of men with ≥ 50% PSA reduction from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['metastatic prostate cancer', 'castration resistant prostate cancer', 'rising PSA'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe purpose of this study is to find out:\n\n* If itraconazole is safe when given at two different doses\n* How itraconazole affects prostate specific antigen (PSA): a blood test that measures substances released by prostate cancer\n* Whether itraconazole can delay further prostate cancer growth and spread\n* How itraconazole affects other markers of prostate cancer', 'detailedDescription': '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.\n\nItraconazole 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed prostate adenocarcinoma.\n* Presence of distant metastases on bone scan, CT scan, or MRI scan.\n* Progression after androgen deprivation (and anti-androgen withdrawal).\n* Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).\n* Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).\n* Age \\> 18 years.\n* ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.\n* Life expectancy \\> 6 months.\n* Adequate kidney, liver, and bone marrow function.\n* Willingness to sign informed consent and adhere to study requirements.\n\nExclusion Criteria:\n\n* Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.\n* Previous chemotherapy for metastatic prostate cancer.\n* Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)\n* Current use of corticosteroids, except if on a stable dose for ≥ 3 months.\n* History of malabsorption syndrome (may affect itraconazole absorption).\n* Allergic reactions to itraconazole or similar compounds.\n* Concurrent use of drugs that interact with the CYP3A4 system (caution only).\n* Presence of known brain metastases.\n* Prior malignancy in the last 3 years, with some exceptions.\n* Uncontrolled major infectious, cardiac, or pulmonary illnesses.\n* Prolonged corrected QT interval (\\> 450 msec) on electrocardiography.'}, 'identificationModule': {'nctId': 'NCT00887458', 'briefTitle': 'A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'A Randomized Phase II Clinical Trial of Two Dose-levels of Itraconazole in Patients With Metastatic Castration-resistant Prostate Cancer', 'orgStudyIdInfo': {'id': 'J0932'}, 'secondaryIdInfos': [{'id': 'JHMI-IRB number: NA_00027099'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low Dose', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)', 'interventionNames': ['Drug: Itraconazole 200 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High Dose', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)', 'interventionNames': ['Drug: Itraconazole 300mg']}], 'interventions': [{'name': 'Itraconazole 200 mg', 'type': 'DRUG', 'description': 'Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)', 'armGroupLabels': ['Low Dose']}, {'name': 'Itraconazole 300mg', 'type': 'DRUG', 'description': 'Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)', 'armGroupLabels': ['High Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael A Carducci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}