NCT01556009

Trial Comparing the Effects of Intermittent Vismodegib vs. PDT in Patients With Multiple Basal Cell Carcinomas

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

Detailed description

This is a Phase II, 28 month, randomized, two arm multicenter clinical study design. During the initial 7 months of the study, all 24 subjects will receive vismodegib, 150mg/day. They then will be randomized in a 1:1 ratio to receive intermittent vismodegib, 150 mg/day, during months 10-13, 16-19, and 22-25 or to receive treatment with PDT at month 10 and at three month intervals thereafter. The safety and efficacy of intermittent vismodegib and of PDT will be assessed at the time of the subjects' visits to the Study Center and at the time of telephone contacts. A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months. The DSMB review will focus on adverse events and efficacy results. Subjects will be monitored for the presence of surrogate endpoint biomarkers (SEBs) at each Study visit.

Conditions

• Basal Cell Nevus Syndrome
• Gorlin's Syndrome

Interventions

Type	Name	Description
DRUG	Vismodegib	150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.
DRUG	Aminolevulinic acid %20 topical solution	20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-03-16
• Last updated: 2020-11-02
• Results posted: 2020-11-02

Locations

3 sites across 1 country: United States