Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04308395
Status:
TERMINATED
Last Update Posted:
2024-09-24
First Post:
2020-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extension Study of Patidegib Topical Gel, 2% in Subjects With Gorlin Syndrome (Basal Cell Nevus Syndrome)
Sponsor:
Organization:
Raw JSON
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{'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ofra.Levy-Hacham@sol-gel.com', 'phone': '+972-73-3729453', 'title': 'VP Clinical & Regulatory Affairs', 'organization': 'Sol-Gel Technologies, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 Year', 'eventGroups': [{'id': 'EG000', 'title': 'Patidegib Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 46, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'No adverse event occured in 5% or more of the patients', 'notes': 'No adverse event occured in 5% or more of the patients', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 82, 'numAffected': 46}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patidegib Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'classes': [{'title': 'Number of subjects with at least one adverse event', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one adverse event related to IMP', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one AE related to IMP leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one paralesional adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one serious adverse event', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one serious adverse event related to IMP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects withat least one adverse event leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of subjects with at least one adverse event related to IMP leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'IMP=Investigational medicinal product; Unique adverse 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Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected"}, {'type': 'SECONDARY', 'title': 'Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patidegib Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected"}, {'type': 'SECONDARY', 'title': 'Change in Dermatology Life Quality Index (DLQI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patidegib Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected"}, {'type': 'SECONDARY', 'title': 'Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patidegib Topical Gel, 2%', 'description': 'Patidegib Topical Gel, 2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'timeFrame': '12 months', 'reportingStatus': 'POSTED', 'populationDescription': "Due to the Sponsor's decision to discontinue the trial, no secondary outcomes data was collected"}, {'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 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2%\n\nPatidegib Topical Gel, 2%: Patidegib Topical Gel, 2%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patidegib Topical Gel, 2%,', 'description': 'All study subjects were treated with Patidegib Topical Gel 2% (the investigational medicinal product \\[IMP\\]), applied topically twice daily to the face.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53.9', 'spread': '13.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '87', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '175.9', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants missing'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '93.1', 'spread': '21.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '29.9', 'spread': '6.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '2 participants missing'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-30', 'size': 972471, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-08-26T03:55', 'hasProtocol': True}, {'date': '2020-04-16', 'size': 304229, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-08-26T03:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All patients will receive Patidegib Topical Gel, 2%,'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'whyStopped': 'Study was terminated early due to low blinded event rate and this study termination is not related to safety of the drug Patidegib Topical Gel, 2%.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2020-03-11', 'resultsFirstSubmitDate': '2024-07-21', 'studyFirstSubmitQcDate': '2020-03-11', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-28', 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': '12 months', 'description': 'IMP=Investigational medicinal product; Unique adverse event = adverse event of a certain preferred term, counted only once within each subject.\n\nRelated adverse event = adverse event with relationship as Definitely, Probably or Possibly.'}], 'secondaryOutcomes': [{'measure': 'Change in Number of Facial BCCs Removed by Surgery', 'timeFrame': '12 months'}, {'measure': 'Change in Number of New Lesions Suspicious for BCC', 'timeFrame': '12 months'}, {'measure': 'Change in Advanced Basal Cell Carcinoma Index (aBCCdex) Lesion Score', 'timeFrame': '12 months'}, {'measure': 'Change in Dermatology Life Quality Index (DLQI)', 'timeFrame': '12 months'}, {'measure': 'Change in EuroQol Group 5-level EQ 5D (EQ 5D 5L)', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gorlin syndrome', 'Patidegib', 'Basal cell nevus syndrome', 'Nevoid basal cell carcinoma syndrome', 'Basal cell carcinoma', 'Hedgehog', 'Surgically eligible basal cell carcinomas', 'BCC', 'BCNS'], 'conditions': ['Basal Cell Nevus Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open label extension study evaluating the safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult subjects with Gorlin syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject must have completed PellePharm Study Pelle-926-201 or Pelle-926-301.\n2. Study Pelle-926-301 subjects must have completed the End of Treatment Visit in Study 301, prior to the Screening Visit in this study. They must also complete all Study 301 related procedures prior to the Baseline Visit of this study.\n3. The subject must be willing to abstain from application of a non-study topical medication (prescription or over the counter) to facial skin for the duration of the trial except as prescribed by the Investigator. Moisturizers and emollients are allowed. Subjects will be encouraged to use their preferred sunscreen with a sunscreen protection factor (SPF) of at least 30 daily on all exposed skin sites.\n4. Female subjects must have a negative pregnancy test. For Study 301 subjects a negative serum pregnancy test result from Study 301 is acceptable if the test was done within 7 days of the Screening Visit of this study.\n5. If the subject is a woman of child bearing potential (WOCBP), she must be willing to use birth control methods which may be considered highly effective. Hormonal contraception must be supplemented with a barrier method (preferably condom). Birth control must start prior to Baseline, continue through the duration of the study, and for 30 days after last application of investigational product (IP).\n6. If the subject is a male with a female sex partner who is a WOCBP, the subject must be willing to use condoms, even after a vasectomy, starting prior to Baseline, through the duration of the study, and for at least 3 months after the last application of IP.\n7. The subject is willing for all facial BCCs to be evaluated and follow treatment recommendations made only by the Investigator.\n8. The subject is willing to forego treatment of facial BCCs with anything other than the study IP except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. In such instances, the only other allowed form of treatment is surgical.\n\nExclusion Criteria:\n\n1. The subject has used topical treatment to the face or systemic therapies that might interfere with the evaluation of the study IP.\n2. The subject has current, recent (within five half lives of the experimental drug or if half life not known, within the past 6 months prior to the Screening Visit), or planned (while enrolled in this study) participation in an experimental drug study (excluding Study 301).\n3. The subject is a WOCBP who is unwilling or unable to comply with pregnancy prevention measures.\n4. 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