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

Status:	Completed
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	8/3/2016
Start Date:	February 2014
End Date:	January 2016

A Randomized, Double-Blind, Placebo-Controlled, Phase II Study To Assess The Efficacy And Safety Of Oral Vismodegib For The Treatment Of Basal Cell Carcinoma Preceding Excision By Mohs Micrographic Surgery

This randomized, double-blind, placebo-controlled study will assess the efficacy and safety
of vismodegib with surgery in patients with basal cell carcinoma. Patients will be
randomized to receive oral daily doses of vismodegib 150 mg or matching placebo. The
anticipated time on study drug treatment is 12 weeks.

Inclusion Criteria:

- Adult patients, >=18 years of age

- 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

We found this trial at

sites

Clinical Trial Facility in West Islip New York

West Islip, New York 11795

from

West Islip, NY