Actively Recruiting
Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Led by National Cancer Center, Japan · Updated on 2023-12-13
32
Participants Needed
6
Research Sites
235 weeks
Total Duration
On this page
Sponsors
N
National Cancer Center, Japan
Lead Sponsor
O
Ono Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have BRAF fusion or rearrangement detected by approved gene panel tests or clinical study
- Disease must be unresectable or recurrent
- No symptomatic brain metastasis, carcinomatous meningitis, or spinal metastasis needing surgery or radiotherapy
- No cardiac effusion, pleural effusion, or ascites requiring treatment
- No anti-cancer drugs within 14 days before registration, nor other study drugs within 21 days before registration
- No surgery under general anesthesia within 28 days before registration
- No radiation therapy within 14 days before registration
- Left ventricular ejection fraction must be 50% or higher within 28 days before registration
- Laboratory tests within 14 days before registration must meet specific blood count and organ function levels
- Able to swallow oral medication
- Women of child-bearing potential must agree to contraception and limited egg donation for at least 30 days after treatment; men must agree to contraception and limited sperm donation for 90 days after treatment
- Written informed consent obtained (for patients under 18, consent from patient and parent or guardian)
- Cohort A: Diagnosed with WHO grade 1 or 2 low-grade glioma; age 12 years or older; if 12-17 years old, weight 40 kg or more; performance status LPS≥70 (age 12-15) or KPS≥70 (16 or older); measurable disease within 28 days before registration; stable neurologically with adequate initial treatment; no multiple lesions or dissemination on MRI; steroid dose ≤50 mg prednisolone equivalent with no increase within 14 days before registration
- Cohort B: Diagnosed with pancreatic cancer; progression after at least one chemotherapy regimen (excluding adjuvant therapy); age 18 or older; ECOG performance status 0 or 1; measurable disease within 28 days before registration on enhanced CT
You will not qualify if you...
- Active second primary cancer except certain fully treated or low-risk cancers
- Symptomatic congestive heart failure (NYHA class II-IV) or arrhythmia over grade 2 within 6 months
- Myocardial infarction or unstable angina within 6 months
- Corrected QT interval over 480 ms in ECG within 14 days before enrollment
- Infections needing systemic treatment
- Uncontrolled high blood pressure (systolic >150 mmHg or diastolic >100 mmHg)
- History or risk factors for retinal vein occlusion or retinal degenerative diseases
- Uncontrolled diabetes mellitus
- Venous thrombus events within 3 months
- Neuromuscular diseases with CK elevation
- Prior treatment with MEK inhibitors
- Severe allergic reaction to binimetinib or its ingredients
- Positive for HIV, hepatitis B surface antigen, or hepatitis C RNA
- Positive for hepatitis B antibodies with detectable HBV DNA
- Gastrointestinal conditions affecting function
- Pregnant or breastfeeding women
- Psychiatric or psychological conditions interfering with trial participation
- Any condition deemed unsuitable by the investigators for participation
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
2
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
3
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
4
Tohoku university Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
5
National Cancer Center Japan
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
6
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Actively Recruiting
Research Team
C
Chigusa Morizane, M.D., Ph.D.
CONTACT
T
Tomoyuki Satake, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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