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

Trial ID:
IRB-13-6241
Seaver Soon
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

Contact Info:

  • Reference Study ID Number: ML28726 www.roche.com/about_roche/roche_worldwide.htm
  • global.rochegenentechtrials@roche.com
  • 888-662-6728