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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Binimetinib 45mg is orally administered twice daily.
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
RECRUITINGHokkaido University Hospital
Sapporo, Hokkaido, Japan
RECRUITINGKyoto University Hospital
Kyoto, Kyoto, Japan
Overall response rate (centrally assessed)
Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.
Time frame: Baseline up to 4 years
Overall response rate (investigator assessed by RECIST)
Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be performed by investigator assessment.
Time frame: Baseline up to 4 years
Overall response rate (investigator assessed by RANO)
Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.
Time frame: Baseline up to 4 years
Overall response rate including minor response(investigator assessed by RANO)
Overall response rate (ORR) defined as the combined incidence of complete response (CR) PR and SD, within cohort A FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on Response Assessment in Neuro-Oncology (RANO) criteria. ORR will be confirmed by local site investigator assessment.
Time frame: Baseline up to 4 years
Progression-free survival
Progression-free survival (PFS) defined as the time from the date of enrollment to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first within cohort A FAS and cohort B FAS.
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Tohoku university Hospital
Sendai, Miyagi, Japan
RECRUITINGNational Cancer Center Japan
Chuo-ku, Tokyo, Japan
RECRUITINGKyushu University Hospital
Fukuoka, Japan
RECRUITINGTime frame: Baseline up to 4 years
Overall survival
Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause within cohort A FAS and cohort B FAS.
Time frame: Baseline up to 4 years
Disease control rate
Disease control rate (DCR) defined as the percentage of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) as the best overall according to RECIST version 1.1 within cohort A FAS and cohort B FAS.
Time frame: Baseline up to 4 years
Duration of response
Duration of Response (DOR) defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first within cohort A FAS and cohort B FAS.
Time frame: Baseline up to 4 years
Adverse event rate
Defined as the percentage of patients who experienced each adverse event. The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG) within cohort A FAS and cohort B FAS.
Time frame: Baseline up to 4 years