Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-04-23 @ 5:56 AM
Study NCT ID:
NCT02735356
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2016-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Itraconazole in Treating Patients With Basal Cell Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-11', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage change of GLi levels in treated vs untreated tumors', 'timeFrame': 'Up to 1 month', 'description': 'will be assessed as relative GLi1 mRNA expression'}], 'secondaryOutcomes': [{'measure': 'Change in BCC tumor size', 'timeFrame': 'At baseline, 1, 4, and 12 weeks', 'description': 'Analyzed based on tumor size change (longest diameter, Response Evaluation Criteria in Solid Tumors \\[RECIST\\] criteria).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Skin Basal Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).\n\nSECONDARY OBJECTIVES:\n\nI. To determine if topical itraconazole gel will decrease BCC size.\n\nOUTLINE:\n\nPatients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.\n\nAfter completion of study treatment, patients are followed up for up to 14 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form\n* The subject must be willing to apply the medications twice daily for 1 month\n* The subjects must have at least four BCCs in non-cosmetically sensitive sites\n* For women of child-bearing potential, a negative urine pregnancy test\n* Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk\n* For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* History of congestive heart failure or other findings of ventricular dysfunction\n* History of current evidence of malabsorption or liver disease\n* Current immunosuppression or taking immunosuppressive drugs\n* Taking oral itraconazole\n* Taking any medication known to affect hedgehog (HH) signaling pathway\n* The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication'}, 'identificationModule': {'nctId': 'NCT02735356', 'briefTitle': 'Topical Itraconazole in Treating Patients With Basal Cell Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Case Study of the Effects of Topical Itraconazole on Pharmacodynamic Modulation of Hedgehog Target Gene Expression in Basal Cell Carcinomas in Patients', 'orgStudyIdInfo': {'id': 'IRB-35672'}, 'secondaryIdInfos': [{'id': 'NCI-2016-00452', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'SKIN0030', 'type': 'OTHER', 'domain': 'OnCore'}, {'id': 'P30CA124435', 'link': 'https://reporter.nih.gov/quickSearch/P30CA124435', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (itraconazole and placebo)', 'description': 'Patients apply itraconazole topically BID and placebo topically BID for 12 weeks.', 'interventionNames': ['Drug: Itraconazole', 'Other: Placebo']}], 'interventions': [{'name': 'Itraconazole', 'type': 'DRUG', 'otherNames': ['Lozanoc', 'Oriconazole', 'R 51,211', 'Sporanox'], 'description': 'Applied topically', 'armGroupLabels': ['Treatment (itraconazole and placebo)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['placebo therapy', 'PLCB', 'sham therapy'], 'description': 'Applied topically', 'armGroupLabels': ['Treatment (itraconazole and placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Anthony Oro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jean Yuh Tang', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Dermatology', 'investigatorFullName': 'Jean Yuh Tang', 'investigatorAffiliation': 'Stanford University'}}}}