Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159478
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-11-28
Brief Title:
Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer Perfume
Sponsor:
National Cancer Center Japan
Organization:
National Cancer Center Japan
Study Overview
Official Title:
Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer Perfume
Status:
RECRUITING
Status Verified Date:
2023-12
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:
Perfume
Brief Summary:
This study is an open-label parallel 2-cohort multicenter investigator-initiated Phase 2 trial to evaluate the efficacy and safety of binimetinib in patients with advanced or recurrent low-grade glioma or pancreatic cancer harboring BRAF fusionrearrangement
Detailed Description:
This study is an open-label parallel 2-cohort multicenter investigator-initiated Phase 2 trial Eligible patients are with recurrent low-grade glioma grade 1 and grade 2 tumors according to WHO classification or advanced or recurrent pancreatic cancer harboring BRAF fusionrearrangement Patients receive binimetinib 45mg administered orally twice daily
Analyses will be performed on each of the two cohorts
Cohort A low-grade glioma Cohort B pancreatic cancer
Analyses will be performed on each of the two cohorts
Cohort A low-grade glioma Cohort B pancreatic cancer
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