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

MIA2017/CT/220

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.

2019-07-23

2024-06-01

2024-06-01

Recruiting

Early phase I

20

Inclusion Criteria: * ≥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 Exclusion Criteria: * Inoperable basal cell carcinoma tumours. * A concurrent cancer diagnosis requiring any systemic anti-cancer therapy. * Serious or unstable pre-existing medical conditions or other conditions or laboratory abnormalities that could interfere with the patient's safety, consent, or compliance. * History of malabsorption or other conditions that would interfere with the absorption of sonidegib. * Known psychiatric or substance abuse disorders that would interfere with cooperation and compliance with the requirements of the trial. * Prior treatment with hedgehog pathway inhibitors. * Concomitant medications that may result in increased or decreased bioavailability of sonidegib. * Patients with neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, rhabdomyolysis, amyotrophic lateral sclerosis and spinal muscular atrophy) due to an increased risk of muscle toxicity with sonidegib. * Male patients expecting to father children or donate sperm during the 12 weeks of sonidegib treatment and for a further 6 months from the end of treatment. * Pregnant or breastfeeding women

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot study which will evaluate the efficacy and safety of short term neoadjuvant sonidegib followed by surgery or imiquimod in the management of basal cell carcinomas in cosmetically challenging locations, assessed by optical coherence tomography and histopathology. The data from this pilot study may lead to the design of larger scale trials of neoadjuvant targeted therapy with the aim to decrease the morbidity of surgical treatment and increase the probability of a curative resection in larger patient populations.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-02-14