Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- BRAF V600 Mutation
- Hepatic Impairment
- Metastatic Melanoma
- Unresectable Melanoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Participants with hepatic impairment will be enrolled sequentially according to their severity.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairment (HI) on the pharmacokinetics and safety of encorafenib in combination with binimetinib, in adult patients with unresectable or metastatic BRAF V600-mutant melanoma. For each participant...
This is an open label, multicentre, phase I study to evaluate the impact of moderate and severe hepatic impairment (HI) on the pharmacokinetics and safety of encorafenib in combination with binimetinib, in adult patients with unresectable or metastatic BRAF V600-mutant melanoma. For each participant, the treatment period will be split in 2 phases: a HI assessment phase assessing the impact of hepatic impairment after a single dose (Day 1) and after repeated doses (Day 15). a post-HI assessment phase: after completing the HI assessment phase, participants may continue treatment in the post-HI assessment phase until disease progression or unacceptable toxicity. Participants with hepatic impairment will be enrolled sequentially according to their severity. The study will start first in participants with normal hepatic function and moderate hepatic impairment respectively. Participants will be assigned to one of the following 3 study groups: Group with normal hepatic function: 4 participants Group with moderate hepatic impairment (Child-Pugh Class B): 4 participants Group with severe impairment (Child-Pugh Class C): 4 participants An Internal Review Committee (IRC) will review the safety and PK data of encorafenib in combination with binimetinib for group with normal hepatic function and group with moderate hepatic impairment and make a recommendation prior to start group with severe impairment enrolment. The Sponsor will determine whether it is safe and feasible to proceed with group with severe impairment. Participants will receive treatment doses according to their assigned group.
Tracking Information
- NCT #
- NCT04759846
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Petr Arenberger Fakultni Nemocnice Kralovske Vinohrady, Czech Republic
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