Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorNational Cancer Center, Japan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BRAF fusion or rearrangement is detected by reimbursed NGS-based cancer gene panel tests, cancer gene panel tests performed under advanced medical treatment, or clinical study (including liquid biopsy).
Unresectable or recurrent
No symptomatic brain metastasis, carcinomatous meningitis or spinal metastasis requiring surgical intervention or radiotherapy
No cardiac effusion, pleural effusion, or ascites requiring treatment
Disqualifiers
Active double primary cancer (but not [1]-[3]): [1] completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, superficial bladder cancer, [2] gastrointestinal cancer curatively resected with ESD or EMR, and [3] other cancers with no recurrence for more than 5 years.
Patients with symptomatic congestive heart failure of NYHA class II-IV or arrythmia (over grade 2) occurring in less than 6 months before registration.
Patients with myocardial infarction or unstable angina occurring in less than 6 months before registration.
Patients with corrected QT interval (QTcF) > 480 ms in ECG performed within 14 days before enrollment.
Trial design
Design model
Single group
Treatments tested in this trial
Binimetinib 15 MG
DrugBinimetinib 45mg is orally administered twice daily.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: BinimetinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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.
Time frame
Baseline up to 4 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Japan
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov