A Pilot Study to Evaluate Short Term Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinomas in Cosmetically Challenging Locations
In this study, patients with BCC will be given neoadjuvant treatment with a drug called sonidegib. Sonidegib is a daily tablet usually given for BCC that cannot be removed by surgery or that has spread through the body. The study aims to see if sonidegib given for 12 weeks will reduce the size of tumours so surgery results in less scarring or may be avoided, with only short term topical treatment required to treat remaining tumour.
• ≥18 years of age.
• Written informed consent.
• Histologically confirmed, resectable, invasive basal cell carcinoma.
• Site and size of BCC considered to be in a cosmetically challenging position for surgery.
• Patient has expressed concerns of the cosmetic outcome of surgery.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Ability to swallow and retain oral medication.
• Anticipated life expectancy of \> 12 months.
• Adequate organ function as demonstrated by blood tests.
• Willing to abstain from blood donations for 20 months from the last dose of sonidegib.
• Men with female partner of childbearing potential to use effective contraception from 14 days prior to study treatment until 6 months after the last dose.
• Female patients with active contraception or no menstrual cycle for \>12 months