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. P atients will be randomized to receive oral daily doses of vismodegib 150 mg or m atching 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