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
Qualifiers
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
Treatments tested in this trial
- Binimetinib 15 MG
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
National Cancer Center, Japan
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov