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

Roche

Status and phase

Terminated

Phase 2

Conditions

Basal Cell Carcinoma

Treatments

Drug: Vismodegib

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01898598

ML28726

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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