NCT06159478

Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: National Cancer Center, Japan · Other Government
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 fusion/rearrangement.

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 fusion/rearrangement. 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

Conditions

• Low-grade Glioma
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Binimetinib 15 MG	Binimetinib 45mg is orally administered twice daily.

Timeline

• Start date: 2023-03-29
• Primary completion: 2027-02-28
• Completion: 2027-09-30
• First posted: 2023-12-06
• Last updated: 2023-12-13

Locations

6 sites across 1 country: Japan