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

  • STATUS
    Recruiting
  • End date
    Sep 2, 2023
  • participants needed
    10
  • sponsor
    Melanoma Institute Australia
Updated on 2 July 2022
scarring
carcinoma
imiquimod
adjuvant therapy
sonidegib

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 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.

Description

Surgery is the first line treatment for most basal cell carcinomas (BCCs) with cure rates of 88 to 96%. However, excision of large lesions in sensitive locations such as the face and scalp may result in disfigurement and impairment of function. Neoadjuvant drug treatment given before surgery aims to reduce tumour size so that surgery and recovery is easier. 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. This approach may also reduce the risk of recurrence. To assess response to treatment, we will use a new technology for skin tumours called optical coherence technology (OCT). This is like an ultrasound scan and is non invasive. OCT can detect the extent and nature of the tumour and build a 3D image with great accuracy. OCT will be used together with pathological analysis of tumour tissue to determine response to sonidegib.

Details
Condition Basal Cell Carcinoma, Basal Cell Carcinoma of Skin, Site Unspecified, Skin Cancer, Invasive Carcinoma
Treatment Surgery, Imiquimod, Sonidegib, Best supportive care
Clinical Study IdentifierNCT03534947
SponsorMelanoma Institute Australia
Last Modified on2 July 2022

Eligibility

Yes No Not Sure

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
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