Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759846
Status:
WITHDRAWN
Last Update Posted:
2023-02-21
First Post:
2020-12-21
Brief Title:
Hepatic Impairment Study of Encorafenib in Combination With Binimetinib in BRAF Melanoma
Sponsor:
Pierre Fabre Medicament
Organization:
Pierre Fabre Medicament
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ie moderate or severe impairment
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 ie moderate or severe impairment
Detailed 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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None