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

Recruiting now · Phase 2

Conditions studied: Low-grade Glioma, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT06159478

Run by

National Cancer Center, Japan

People needed

32

Starts

2023-03-29

Expected to finish

2027-09-30

Last updated by the study team

2023-12-13

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria for both cohort A and B
• 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
• Not received anti-cancer drug within 14 days before registration, nor received other study drug (molecular targeting drug, immune therapy) within 21 days before registration
• Not received operation under general anesthesia within 28 days before registration
• Not received radiation therapy (including gamma knife, cyber knife) within 14 days before registration
• Left ventricular ejection fraction >= 50% by echocardiography or MUGA (multigated acquisition scan) within 28 days before registration
• Having all laboratory tests performed within 14 days before registration and the values are within the following range. Patients should not receive administration of G-CSF and/or blood transfusion within 14 days before the blood collection (1) Absolute neutrophil count >= 1.500/mm3 (2) Platelet count >= 10.0 X 10(4))/mm3 (3) Hemoglobin >= 8.0 g/dL (4) Total bilirubin <= 1.5 g/dL (5) Aspartate aminotransferase (AST) <= 100 U/L (6) Alanine aminotransferase (ALT) <= 100 U/L (7) Serum creatinine <= 1.5 mg/dL
• Patients who are able to swallow orally administered medication.
• Consent to at least 30 days of contraception and limited egg donation (including egg retrieval for future egg transfer) after last administration of study drug for child-bearing status women. Consent to 90 days of contraception and limited sperm donation after last administration of study drug for men.
• Written informed consent (When registering patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian.)
• Cohort A
• Histopathologically diagnosed as low-grade glioma, based on WHO classification of 2007, 2016 and 2021. The grade is WHO grade 1 or 2.
• Age at the time of registration is 12 years or older (When registering a patient under 18, a signed consent form must be obtained from both the patient and the parent or legal guardian), and patients who are 12-17 years old have to be 40 kg or over in body weight. There is no limitation in body weight for patients who are 18 years or older.
• Lansky Performance Status (LPS) >= 70 for patients 12-15 years old Karnofsky Performance Status (KPS) >= 70 for patients 16 years or older
• Having measurable disease within 28 days before registration
• Patients suffice the following. (1) Having adequate initial treatment depending on the primary central nervous tumor including surgery if recommended treatment is available. (2) Neurologically stable.
• (3) Multiple lesion or dissemination is not detected with MRI at the registration.
• Not increased steroid for low-grade glioma within 14 days before registration and the dosage of steroid in equivalent to 50 mg prednisolone or less.
• Cohort B 19) Histopathologically diagnosed as pancreatic cancer (histologically not specified).
• Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.
• Age at the time of registration is 18 years or older. 22) Performance Status (ECOG) is 0 or 1 23) Having measurable disease within 28 days before registration detected by enhanced CT (Head, chest, abdominal, pelvic: under 5 mm in slice)

You may not qualify if…

• 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.
• Patients with infections requiring systemic treatment.
• Patients with uncontrolled hypertension (systolic blood pressure: over 150 mmHg or diastolic blood pressure: over 100 mmHg).
• Patients with history or findings of retinal vein occlusion (RVO) or having RVO risk factor (unstable glaucoma, ocular hypertension, hyperviscosity syndrome, hypercoagulability syndrome, etc.)
• Patients with history or complication of retinal degenerative disease other than RVO (central serous chorioretinopathy, retinal detachment, age-related macular degeneration, etc.)
• Patients with uncontrolled diabetes mellitis.
• Patients with venous thrombus (transient ischemic attack, stroke, massive deep vein thrombosis, pulmonary embolism, etc.) occurring in less than 3 months
• Patients who have neuromuscular disease with CK elevation (inflammatory myopathy, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, etc.).
• Prior treatment with MEK inhibitors.
• Previous severe hypersensitive reaction to ingredient including binimetinib.
• Patients who are positive for either HIV antibody, HBs antigen, or HCV-RNA.
• Negative for HBs antigen, positive for HBs antibody or HBc antibody, and positive for HBV-DNA assay. (If it is less than or equal to the detection sensitivity, patients are not excluded)
• Patients with concomitant diseases that affect gastrointestinal function.
• Women who are pregnant, breastfeeding and need to continue breastfeeding in the future, and women who may be pregnant.
• Patients with psychiatric diseases or psychological symptoms interfering with participation in the trial.
• Patients who are deemed inappropriate for participation in the trial by the principal investigator or sub-investigator.

Where it is running

• National Cancer Center Hospital East — Kashiwa, Chiba, Japan (enrolling)
• Hokkaido University Hospital — Sapporo, Hokkaido, Japan (enrolling)
• Kyoto University Hospital — Kyoto, Kyoto, Japan (enrolling)
• Tohoku university Hospital — Sendai, Miyagi, Japan (enrolling)
• National Cancer Center Japan — Chuo-ku, Tokyo, Japan (enrolling)
• Kyushu University Hospital — Fukuoka, Japan (enrolling)

Full record on ClinicalTrials.gov

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