Status:
RECRUITING
Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Lead Sponsor:
National Cancer Center, Japan
Collaborating Sponsors:
Ono Pharmaceutical Co. Ltd
Conditions:
Low-grade Glioma
Pancreatic Cancer
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 g...
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 c...
Eligibility Criteria
Inclusion
- 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.
- 18\) 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).
- 20\) Having progression after at least one regimen of chemotherapy excluding adjuvant therapy.
- 21\) 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)
Exclusion
- 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.
Key Trial Info
Start Date :
March 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06159478
Start Date
March 29 2023
End Date
September 30 2027
Last Update
December 13 2023
Active Locations (6)
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1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
2
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
3
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
4
Tohoku university Hospital
Sendai, Miyagi, Japan, 980-8574