NCT01631331

Vismodegib in Treating Patients With Basal Cell Carcinoma (BCC)

A Pilot Study to Investigate the Off Label Use of Vismodegib as an Adjuvant to Surgery for Basal Cell Carcinoma Tumors (BCCs)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn about the effect of vismodegib on sporadic basal cell carcinoma (BCCs) prior to surgical removal.

Detailed description

PRIMARY OBJECTIVES: I. The percent reduction in surgical defect area/size surrounding BCC tumor pre and post-vismodegib. SECONDARY OBJECTIVES: I. Recurrence rate post treatment II. Safety, tolerability and percent drop-out after 3 vs. 6 months of vismodegib in otherwise healthy patients. OUTLINE: Patients receive vismodegib orally (PO) once daily (QD) for up to 3 months if the initial BCC size is \< 2 cm and superficial or for up to 6 months if the initial BCC size is \>= 2 cm or non-superficial. After completion of vismodegib treatment, patients undergo Mohs surgery. After completion of study treatment, patients are followed up for an average of 24 months.

Conditions

• Basal Cell Carcinoma of the Skin
• Recurrent Skin Cancer

Interventions

Type	Name	Description
DRUG	vismodegib	Given PO
PROCEDURE	Mohs surgery	Undergo Mohs surgery

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-09-17
• Completion: 2016-05-31
• First posted: 2012-06-29
• Last updated: 2017-12-08
• Results posted: 2017-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study