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This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle in patients with Basal Cell Carcinoma. One investigational center (metasite) in the United States will participate in this study. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel.
This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle. Approximately 36 subjects who meet the study entry criteria will be enrolled into one of four sequential cohorts. As soon as one cohort has been completely enrolled, the next cohort will be enrolled. Each subject will treat no more than two previously untreated biopsy confirmed treatment-targeted nodular BCCs. If the subject has additional non-treatment targeted BCCs they can be treated surgically prior to or during the trial. Within each cohort subjects will be randomized in a 2:1 ratio to receive active or vehicle gel. The sequential cohorts will be:
- Cohort 1: patidegib gel 2% or vehicle, once daily
- Cohort 2: patidegib gel 4% or vehicle, once daily
- Cohort 3: patidegib gel 2% or vehicle, twice daily
- Cohort 4: patidegib gel 4% or vehicle, twice daily
The study drug will be applied topically to the treatment-targeted BCCs and a rim or adjacent skin for 12 weeks. Information on reported and observed adverse events (AEs) will be obtained at each visit. An abbreviated physical examination (PE) will be performed at Baseline and Week 12. The treatment-targeted BCCs will be identified by the Investigator at the Baseline visit and will be circled in ink, photographed, and measured at all study visits (Baseline, Weeks 2, 6, 8, 10, and 12). Blood samples for complete blood count and serum chemistry and urine for urinalysis will be collected from subjects at Screening, Week 6, and Week 12. Subjects who terminate study participation early will be asked to complete all Week 12 assessments, as appropriate, prior to commencement of any alternative therapy for BCCs (if possible). Subjects who discontinue from the study during the treatment period will not be replaced.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Basal Cell Carcinomas
patidegib gel 2% - cohort 1, patidegib gel 4% - cohort 2, Vehicle - cohort 1, patidegib gel 2% - cohort 3, patidegib gel 4% - cohort 4, vehicle - cohort 2, Vehicle - cohort 3, Vehicle - cohort 4
Science 37, Inc
Not yet recruiting
Published on BioPortfolio: 2016-07-12T00:53:21-0400
Multicenter, double-blind, randomized, vehicle-controlled evaluates the efficacy and safety of patidegib gel, 2% and 4% in comparison with vehicle in subjects at least 18 years of age that...
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