NCT04806646

Tailored Sonidegib Schedule After Complete Response in BCC

A Phase II, Open-label Study Improving Compliance and Time of Treatment After Obtaining Complete Response Through a Tailored Schedule of Sonidegib in Locally Advanced Basal Cell Carcinomas (BCC) - the SONIBEC Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

One cycle of therapy is defined as 28 days of sonidegib. The patient will start with first schedule. * Treatment schedule 1 (TS1): assumption 14 days on and 14 days off. TS1 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, at treatment resumption they will start the TS2 schedule. * Treatment schedule 2 (TS2): assumption 7 days on and 21 days off. TS2 may be temporary interrupted for any grade 2 or 3 toxicity (excluding alopecia) until return to grade 1. If the patient experiences any grade 3 or 2 side effects lasting for more than 28 days, he/she is discontinued from the study. If progression of disease is observed (during TS1 or TS2) the patient is discontinued from the study.

Conditions

• Locally Advanced Basal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sonidegib	TS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off.

Timeline

• Start date: 2021-01-12
• Primary completion: 2024-01-12
• Completion: 2026-01-12
• First posted: 2021-03-19
• Last updated: 2022-08-04

Locations

1 site across 1 country: Italy