jRCTs041200030已完成不适用
A feasibility study of patient-proposed healthcare services with oral entrectinib in patients with ROS1-fusion-positive pediatric brain tumors (ROSE study)
未提供0 个研究点目标入组 1 人开始时间: 2020年8月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 15age old under（—）
- 性别
- All
入选标准
- •1.Primary brain tumors with ROS1 gene fusions that are locally advanced; gene fusions are defined as those predicted to translate into a fusion protein with a functional ROS1 kinase domain, without a concomitant second oncodriver (e.g. known, activating mutations in EGFR, KRAS) as determined by a nucleic acid-based diagnostic testing method approved in Japan.
- •2.Patients who have no satisfactory treatment options for primary CNS tumors.
- •3.Performance status: PS (ECOG) 0-2 and minimum life expectancy of at least 4 weeks.
- •4.Age: Male or female from birth to age <=15 years.
- •5.Patients must have measurable or evaluable disease, as defined in RANO. Measurable disease is defined as bidimensionally contrast enhancing lesions with clearly defined margins by CT or MRI scan, with two perpendicular diameters of at least 10 mm, visible on two or more axial slices that are preferably, at most, 5 mm apart with 0-mm skip.
- •6.No prior treatment with approved or investigational ROS1 inhibitors.
- •7.Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment.
- •8.XRT/External Beam Irradiation: >=14 days after whole brain XRT;>=7 days after stereotactic radiation surgery.
- •9.Organ function;
- •i. ANC >= 1,000/microL;
- •ii. Hemoglobin >= 8.0 g/dL (without transfusion within 14 days of registration)
- •iii. Platelet count >= 75,000/microL (without transfusion)
- •iv. Bilirubin <= 1.5 mg/dl
- •v. ALT <= 3 x upper limit of normal (ULN)
- •vi. Serum creatinine <= ULN for age (5>=; 0.8mg/dl, 5-10; 1.2mg/dl and 10<=; 1.5mg/dl)
- •vii. ECG with QTcF <= 480 msec
- •Written informed consent: A signed informed consent and/or assent for study participation will be obtained from patients, parents or caregivers. (Written informed consent should be obtained from patients more than 7 years old.).
排除标准
- •1.Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
- •Active infection requiring systemic therapy.
- •3.Body temperature >= 38 degrees Celsius at registration.
- •4.Women during pregnancy, possible pregnancy or breast-feeding.
- •5.Continuous systemic use of immunosuppressant including steroid.
- •6.Uncontrolled diabetes mellitus or routine administration of insulin.
- •7.Congestive heart failure within 3 months or ejection fraction <= 50%.
- •8.Inadequately controlled hypertension.
- •9.Known congenital long QT syndrome.
- •10.Familial history of long QT syndrome.
- •11.Positive HBs antigen, positive HBs antibody or positive HBc antibody.
- •12.Positive HCV antibody.
- •13.Positive HIV antibody.
- •14.Pneumonitis, pulmonary fibrosis, or severe lung emphysema on chest CT.
- •15.Patients who were judged as inappropriate for entry in this study by the principal investigator or sub-investigators.
结局指标
主要结局
-
Overall best response until four courses
次要结局
未报告次要终点
研究者
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