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New treatment option for Low-grade Glioma
Official title Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
ClinicalTrials.gov ID: NCT06159478
What this study is testing
What is Binimetinib 15 MG?
Binimetinib 15 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for low-grade glioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- Active double primary cancer (but not [1]-[3]): [1] completely resected following cancers: basal cell carcinoma, stage I squamous cell carcinoma...
- Patients with symptomatic congestive heart failure of NYHA class II-IV or arrythmia (over grade 2) occurring in less than 6 months before...
- 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).
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kashiwa, Chiba, Japan
- Sapporo, Hokkaido, Japan
- Kyoto, Kyoto, Japan
- Sendai, Miyagi, Japan
- Chuo-ku, Tokyo, Japan
- Fukuoka, Japan
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kashiwa, Chiba, Japan; Sapporo, Hokkaido, Japan; Kyoto, Kyoto, Japan; Sendai, Miyagi, Japan; Chuo-ku, Tokyo, Japan; Fukuoka, Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.