A trial to evaluate whether encorafenib is safe in Chinese mainland participants with BRAFV600E advanced solid tumors

A multicenter, open-label, phase 1 study investigating the safety and tolerability of encorafenib monotherapy in BRAF^V600E-mutated Chinese patients with advanced metastatic solid tumors

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Status

Status :

Completed

Type of study

Phase I

Min. Age

Years old

Max. Age

Gender

All

Brief summary

Encorafenib is a marketed drug (Braftovi®) approved to treat patients with certain skin cancer (melanoma) and certain colorectal cancer in several countries (European Union, USA, Australia, Japan, Switzerland...).
Limited clinical information of encorafenib used as a single drug (monotherapy) or in combination with other drugs are available specifically in Chinese patients whose tumor has a specific mutation in the BRAF gene (BRAFV600E mutation).
The purpose of this trial is to investigate the safety of encorafenib in Chinese participants with BRAF V600E solid tumors..

Therapeutic area :

Oncology

Disease :

Advanced solid tumors: skin cancer (melanoma) or lung cancer (non-small cell lung cancer)

Study medication :

Encorafenib (BRAFTOVI®)

Phase : Phase I

Start Date :

15 September 2021

End Date / Planned study Completion Date :

06 May 2022

Study ID : W00090GE102