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

NCT04759846 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-02-21

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Encorafenib + Binimetinib

The doses administered to patients with normal hepatic function will be the same as the recommended commercialised doses

DRUG

Encorafenib + Binimetinib

A smaller dose than the dose approved for patients with normal hepatic function has been defined

DRUG

Encorafenib + Binimetinib

A smaller dose than the dose approved for patients with normal hepatic function has been defined

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Petr Arenberger · Fakultni Nemocnice Kralovske Vinohrady, Czech Republic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Czechia
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759846 on ClinicalTrials.gov