drugset / Trial / NCT04759846

Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma

NCT04759846

Phase 1 Withdrawn Pierre Fabre Laboratories
Non-randomizedSequentialOpen-labelTreatment

Summary

Encorafenib in combination with binimetinib have been approved in USA, Europe, Australia, Japan and Switzerland for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600 mutation. The main objective of this study is to find a safe and effective dose of encorafenib in combination with binimetinib for patients who have BRAF-mutant metastatic or unresectable melanoma with hepatic dysfunction (i.e. moderate or severe impairment).

Timeline

Start
2021-01-21
Primary completion
2023-05
Completion
2023-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Binimetinib Small molecule
Subject Encorafenib Small molecule

Indications