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

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A multicenter, open-label, phase 1 study investigating the safety and tolerability of encorafenib monotherapy in BRAFV600E-mutated Chinese patients with advanced metastatic solid tumors

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Status
Status :
Completed
Type of study
Phase I
Min. Age
18
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
CT.gov Number : NCT05003622
Countries :
China

Find out where the clinical trial was conducted ?

1

Sun Yan-Sen University Cancer Center

651 East Dongfeng Lu
Guangzhou guangdong
510060
China

Last update at : 15 November 2023

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