At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 24 enrolled
Drug / intervention
Vismodegib +1 moredrug
Likely dose
Vismodegib 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Open Label Trial Comparing the Effects of Intermittent Vismodegib Versus PDT on the Maintenance of Benefit Following 7 Months of Continuous Vismodegib Treatment in Patients With Multiple Basal Cell Carcinomas
In Brief
A Phase 2 clinical trial evaluating Vismodegib and Aminolevulinic acid %20 topical solution for Basal Cell Nevus Syndrome and Gorlin's Syndrome. Completed, enrolled 24 participants across 3 sites.
Detailed Summary
The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBasal Cell Nevus Syndrome, Gorlin's Syndrome
CountriesUnited States
CollaboratorsGenentech, Inc.
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionDec 2015
TodayJul 2026
First PostedMar 16, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.3 years ago
Interventions
Vismodegibdrug
150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.
Aminolevulinic acid %20 topical solutiondrug
20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.