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

Overview

About this study

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 m atching placebo. The anticipated time on study drug treatment is 12 weeks.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Shari Ochoa, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20111988

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