Using sonidegib before surgery to treat basal cell carcinoma

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

This study is testing if taking a daily pill called sonidegib before surgery can shrink basal cell carcinoma tumors in sensitive areas to make surgery easier or possibly avoid it altogether.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Melanoma Institute Australia (other)
• Locations: 1 site (North Sydney, New South Wales)
• Trial ID: NCT03534947 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sonidegib, a daily oral medication, as a neoadjuvant treatment for patients with resectable basal cell carcinoma (BCC) located in cosmetically sensitive areas. The goal is to reduce tumor size over a 12-week period, potentially allowing for less invasive surgery or even avoiding surgery altogether. The study will utilize optical coherence technology (OCT) to assess tumor response and guide treatment decisions. By combining drug treatment with advanced imaging techniques, the study aims to improve surgical outcomes and reduce the risk of recurrence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed, resectable invasive basal cell carcinoma in cosmetically challenging locations.

Not a fit: Patients with inoperable basal cell carcinoma or those requiring systemic anti-cancer therapy for concurrent cancer diagnoses may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less scarring and improved cosmetic outcomes for patients with basal cell carcinoma.

How similar studies have performed: Other studies have shown promise with neoadjuvant therapies for skin cancers, but this specific approach using sonidegib is relatively novel.

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

Where this trial is running

North Sydney, New South Wales

• Melanoma Institute Australia — North Sydney, New South Wales, Australia (RECRUITING)

Study contacts

• Study coordinator: Pascale Guitera, MD PhD

Conditions: Basal Cell Carcinoma, Basal Cell Carcinoma of Skin, Site Unspecified, Skin Cancer, Invasive Carcinoma, Neoadjuvant, Sonidegib