NCT06159478招募中2 期
Phase II Investigator-initiated Trial of Binimetinib in Patients With BRAF Fusion-positive Low-grade Glioma or Pancreatic Cancer (Perfume)
National Cancer Center, Japan6 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 6
- 主要终点
- Overall response rate (centrally assessed)
研究概览
简要总结
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.
详细描述
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 classification) or advanced or recurrent pancreatic cancer harboring BRAF fusion/rearrangement. Patients receive binimetinib 45mg administered orally, twice daily.
Analyses will be performed on each of the two cohorts:
Cohort A: low-grade glioma Cohort B: pancreatic cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.)
- •Histopathologically diagnosed as low-grade glioma, based on WHO classification of 2007, 2016 and
- •The grade is WHO grade 1 or
- •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)
排除标准
- •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.
研究组 & 干预措施
Binimetinib
Experimental
干预措施: Binimetinib 15 MG (Drug)
结局指标
主要结局
Overall response rate (centrally assessed)
时间窗: Baseline up to 4 years
Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, within cohort A FAS, cohort B FAS, and confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.
次要结局
- Overall response rate (investigator assessed by RECIST)(Baseline up to 4 years)
- Overall response rate (investigator assessed by RANO)(Baseline up to 4 years)
- Overall survival(Baseline up to 4 years)
- Disease control rate(Baseline up to 4 years)
- Duration of response(Baseline up to 4 years)
- Progression-free survival(Baseline up to 4 years)
- Adverse event rate(Baseline up to 4 years)
- Overall response rate including minor response(investigator assessed by RANO)(Baseline up to 4 years)
研究者
研究点 (6)
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