Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02828111
Status:
COMPLETED
Last Update Posted:
2019-01-08
First Post:
2016-07-01
Brief Title:
Clinical Trial of Patidegib Gel 2 4 and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas
Sponsor:
PellePharm Inc
Organization:
PellePharm Inc
Study Overview
Official Title:
Double-Blind Dose Escalating Randomized Vehicle-Controlled Proof of Concept Clinical Trial of Patidegib Gel 2 4 and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCC
Brief Summary:
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 21 ratio to receive active or vehicle gel
Detailed Description:
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 21 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 of 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 at Baseline Weeks 6 and 12 and 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
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 of 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 at Baseline Weeks 6 and 12 and 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None