A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma

• Status: Terminated
• Trial end date: 2016-01-26
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma

• Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site

• Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

• Prior treatment with vismodegib

• Known hypersensitivity to any of the study drug excipients

• Any metastatic basal cell carcinoma

• Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery

• Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)

• Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination

• Recent, current, or planned participation in another experimental drug study