A trial to evaluate the impact of liver dysfunction on elimination of encorafenib in combination with binimetinib administered to patients with BRAFV600E-mutant solid tumors

An open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairments on the pharmacokinetics and safety of encorafenib in combination with binimetinib in adult patients with unresectable or metastatic BRAF V600-mutant solid tumors.

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Status

Status :

Recruiting

Type of study

Phase I

Min. Age

Years old

Max. Age

Gender

All

Brief summary

Encorafenib (marketed under the name "BRAFTOVI®") has shown efficacy in several BRAF V600 mutant solid cancers; specifically, the combination of encorafenib and binimetinib (marketed under the name "MEKTOVI®") is effective and well tolerated in patients with advanced melanoma whose tumor harbor the BRAF V600 mutation.

The liver plays an important part in the way encorafenib is absorbed and then eliminated from the body. Previous clinical trials suggest that elimination is slower for patients having liver dysfunctions (also called HI, for Hepatic Impairment). Following daily administrations, this leads to higher treatment concentration in the body. According to the severity of HI, daily doses of encorafenib and binimetinib may need to be adapted.

The purpose of this study is to assess the recommended dose in patients presenting moderate or severe HI.

Therapeutic area :

Oncology

Disease :

Unresectable or metastatic BRAFV600E-mutant solid tumors

Study medication :

Encorafenib (BRAFTOVI®) - Binimetinib (MEKTOVI®)

Phase : Phase I

Start Date :

30 May 2022

End Date / Planned study Completion Date :

December 2023

Study ID : W00090GE101