A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

Launched by MELANOMA INSTITUTE AUSTRALIA · May 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a medication called sonidegib, which is given as a daily tablet to patients with a type of skin cancer known as basal cell carcinoma (BCC). The goal is to see if taking sonidegib for 12 weeks can shrink the size of the tumors. This may help patients either have surgery with less scarring or possibly avoid surgery altogether, only needing a short-term topical treatment to manage any remaining tumor.

To participate in this study, patients need to be at least 18 years old and have a specific type of invasive BCC that can be surgically removed but is located in a challenging area for surgery. They should also be in good overall health and able to take oral medication. The trial is currently recruiting participants, and anyone considering joining should discuss it with their doctor to see if it’s a good fit for them. Additionally, both men and women in the trial will need to follow specific guidelines regarding contraception to ensure safety during treatment.

Gender

ALL

Eligibility criteria

• 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