Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Placebo
  • Drug: Vismodegib

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting