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Brief Title: Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Official Title: Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Study ID: NCT06159478
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 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
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Kyoto University Hospital, Kyoto City, Kyoto, Japan
Tohoku university Hospital, Sendai, Miyagi, Japan
National Cancer Center Japan, Chuo-ku, Tokyo, Japan
Kyushu University Hospital, Fukuoka, , Japan