NCT02067104

Vismodegib in Basal Cell Carcinomas (BCC) Chemoprevention

A Placebo Controlled Double-Blind Study to Evaluate the Efficacy of Vismodegib as Chemoprevention of New Bcc Development in High Risk Subjects

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single site double blinded Phase II study to evaluate the chemopreventative effectiveness of vismodegib in the treatment of subjects at high risk for developing basal cell carcinomas (BCC).

Detailed description

The primary objective of this study will be to determine if vismodegib pulse therapy will significantly reduce the incidence of newly diagnosed basal cell carcinomas (BCC) in high risk individuals when compared with placebo, as measured by the incidence of biopsy confirmed BCC over a 24 month period. The secondary objective will be to determine that there will be no difference in the incidence of newly diagnosed squamous cell carcinomas (SCC) in the same subjects receiving vismodegib treatment when compared with placebo, as measured by the incidence of biopsy confirmed SCC over the same 24 month period.

Conditions

• Basal Cell Carcinomas

Interventions

Type	Name	Description
DRUG	Vismodegib	Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
DRUG	Placebo	Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.

Timeline

• Start date: 2014-02-17
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2014-02-20
• Last updated: 2019-08-14
• Results posted: 2019-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study