A Study of Vismodegib With Surgery in Participants With Previously Untreated Basal Cell Carcinoma
Trial ID or NCT#
NCT01898598
Status
NOT RECRUITING
Purpose
This randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Sumaira Z. Aasi, MD
Dermatologist,
Mohs surgeon,
Cutaneous oncology specialist,
Dermatologic surgeon
Clinical Professor, Dermatology
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
