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

Skin Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Basal Cell Carcinoma of Skin, Site Unspecified
• Carcinoma
• Carcinoma, Basal Cell
• Invasive Carcinoma
• Skin Cancer

• NCT number: NCT03534947
• Study type: Interventional
• Source: Melanoma Institute Australia
• Contact: Pascale Guitera, MD PhD
• Phone: +61299117296
• Email: pascale.guitera@melanoma.org.au
• Status: Recruiting
• Phase: Phase 2
• Start date: July 23, 2019
• Completion date: June 2024