Italian Cancer Group started SONIBEC Trial: Improving Compliance and Time of Treatment After Obtaining Complete Response Through a Tailored Schedule of Sonidegib in Locally Advanced Basal Cell Carcinomas
Gruppo Oncologico del Nord-Ovest is commencing recruitment for the clinical trial of the Tailored Sonidegib Schedule After Complete Response in BCC.
The condition is Locally Advanced Basal Cell Carcinoma.
A new clinical trial is recruiting patients in the following locations: Italy.
The trial officially began on January 12, 2021, and is planned to complete on January 12, 2026.
Adult patients with locally advanced BCC, not amenable to surgical treatment and who obtained a complete response (CR) to Hedgehog inhibitors are administered a tailored schedule of the study drug. The tailored schedule consists of a change in the time of drug assumption. It implements some weeks of assumption and some weeks of suspension of sonidegib rather than a continuous administration.
Among the criteria that allow participation, the following are indicated:
- Age ≥ 18 years.
- Histologic confirmation of locally advanced BCC lesion.
- Patient having shown a complete response (CR) to Hedgehog inhibitor sonidegib within the 3 months prior to the screening. In BCC every effort should be made to obtain histologic confirmation of CR mainly in case of doubt, performing several biopsies in the sites where disease was present. CR must have been confirmed by 2 consecutive radiologic exams and by visual and dermoscopic examinations.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- For women of childbearing potential, a negative pregnancy test within 7 days prior to commencement of dosing is required.
- For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with sonidegib, and for 6 months after the last dose was received.
The full list can be viewed at the link below.
The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT04806646
