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 :
Completed
Type of study
Phase I
Min. Age
18
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
EudraCT/CTIS number : 2020-000861-17
CT.gov Number : NCT04759846
Countries :
Czech Republic
Italy
Spain

Find out where the clinical trial is conducted

1

Hospital Universitario Virgen Macarena

Avenida Doctor Fedriani 3 Planta Sotano
41009 Seville
Spain

2

Hospital Vall Hebron-VHIO

Passeig Vall Hebron 119-129,
08035 Barcelona
Spain

3

Hospital General de Valencia

Avenida de les Tres Creus, 2
46014 Valencia
Spain

4

IRCCS Istituto Europeo Di Oncologia (ieo)

Via Ripamonti n. 435
20141 Milano
Italy

5

IRCCS IRST

Via P. Maroncelli 40
47014 Meldola
Italy

6

Fondazione Irccs Istituto Nazionale Dei Tumori di Milano

Via Giacomo Venezian 1
20133 Milano
Italy

7

Azienda Ospedaliera Universitaria Pisana

Via Roma 67,
56126 Pisa
Italy

8

Azienda Ospedaliero

viale Bracci N° 16
53100 Siena
Italy

9

Fakultní nemocnice Olomouc

I. P. Pavlova 185/6
779 00 Olomouc
Czechia

10

Fakultni Nemocnice Kralovske Vinohrady

Srobarova 1150/50
10034 Praha
Czechia

Last update at : 09 September 2024

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