Brief Summary
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 surgerytreatment involving removal of cancerous tissue and/or tumours and a margin of healthy tissue around it to reduce recurrence 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 tumoura tissue mass that forms from groups of unhealthy cells.
Intervention / Treatment
- Drug: Sonidegib
- Drug: Imiquimod
- Procedure: Surgery
- Other: Best supportive care
Inclusion Criteria
- ≥18 years of age.
- Written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment..
- Histologically confirmed, resectable, invasive basal cell carcinomacancer arising from tissues that line organs.
- 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 Oncologythe study, diagnosis and treatment of cancer 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 teststesting done to measure the levels of certain substances in the blood.
- Willing to abstain from bloodthe red bodily fluid that transports oxygen and other nutrients around the body donations for 20 months from the last dosethe amount of medication taken 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