Spots Global Cancer Trial Database for Tailored Sonidegib Schedule After Complete Response in BCC

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Trial Identification

Brief Title: Tailored Sonidegib Schedule After Complete Response in BCC

Official Title: 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

Study ID: NCT04806646

Conditions

Locally Advanced Basal Cell Carcinoma

Interventions

Sonidegib

Study Description

Brief 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.