Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03839342
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2019-02-08
Brief Title:
Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Binimetinib and Encorafenib for the Treatment of Advanced Solid Tumors With Non-V600E BRAF Mutations
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAVER
Brief Summary:
This is a single-centre open-label Phase II study of the investigational drugs binimetinib and encorafenib that will be taken my mouth orally daily in adult patient with advanced andor metastatic solid tumors for which no other standard therapy is available The main purpose is to evaluate the objective response rate ORR of the study drugs in the growth of the cancer in patients with class 2 and 3 BRAF mutations
Detailed Description:
BRAF is a gene in humans that is commonly altered in cancer resulting in a change to the proteins created from this mutation These altered proteins interact with a process in the body known as the MAPK mitogen-activated protein kinase pathway and promote the growth of cancer Three classes of BRAF mutations have been identified to understand why some patients respond to treatment and others do not Class 2 and 3 BRAF mutations have worse overall survival This study will look at participants in these classes non-V600E BRAF mutations
Binimetinib is an oral drug tablet that stops the function of MEK mitogen-activated protein kinase kinase MEK is a part of the MAPK pathway so blocking this step helps in stopping the pathway from confinuing to grow the cancer
Encorafenib is an oral drug capsule that stops the function of BRAF V600-mutant kinase the protein that is produced from a type of BRAF gene mutation This protein promotes the MAPK pathway so blocking this protein stops the MAPK pathway from growing the cancer
Patients will visit the clinic up to 2 times every 4 weeks 1 cycle for tests and procedures while taking the study drugs daily Procedures will involve review of medication and history imaging scans blood sample collection for safety and research purposes urine collection ECGs eye exam MUGA scans and mandatory and optional tumor biopsies
Binimetinib is an oral drug tablet that stops the function of MEK mitogen-activated protein kinase kinase MEK is a part of the MAPK pathway so blocking this step helps in stopping the pathway from confinuing to grow the cancer
Encorafenib is an oral drug capsule that stops the function of BRAF V600-mutant kinase the protein that is produced from a type of BRAF gene mutation This protein promotes the MAPK pathway so blocking this protein stops the MAPK pathway from growing the cancer
Patients will visit the clinic up to 2 times every 4 weeks 1 cycle for tests and procedures while taking the study drugs daily Procedures will involve review of medication and history imaging scans blood sample collection for safety and research purposes urine collection ECGs eye exam MUGA scans and mandatory and optional tumor biopsies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None