Basket Study of Brigatinib in Patients with Advanced Solid Tumors with ROS1 Rearrangement

Department of Thoracic Oncology, National Cancer Center Hospital East0 个研究点目标入组 52 人开始时间: 2019年7月10日最近更新: 2023年10月17日

研究概览

暂无简介。

•Main Inclusion Criteria
•1) Histologically- or cytologically-confirmed diagnosis of advanced or recurrent solid tumor.
•2) Known ROS1 fusion gene-positive determined using tissues or blood.
•3) Prior treatment with crizotinib is permitted
•4) At least 1 non-irradiated measurable lesion according to RECIST v1.1
•5) Males and females age 20 years or above on the date of informed consent for study participation
•6) An ECOG PS score of 0-2
•7) Has adequate organ function
•8) Received an explanation with a document about the study and signed informed consent form before enrollment.

•Main Exclusion Criteria:
•1) ALK fusion gene positive.
•2) Any prior treatment including chemotherapy, radiotherapy, and surgery within 2 weeks prior to enrollment.
•3) Has not recovered to grade 1 from acute toxicity of prior treatment.
•4) Symptomatic brain metastases.
•5) Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function, carcinomatous meningitis, or leptomeningeal disease.
•6) CT-confirmed or a history of interstitial fibrosis, pneumonitis or interstitial lung disease.
•7) Any of Myocardial infarction, Severe or unstable angina, Heart failure, etc. within 3 months prior to the start of study treatment.
•8) Ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade > 2, uncontrolled atrial fibrillation of any grade, and QTc > 470 msec or uncontrolled hypertension or high glucose (>=CTC grade 3).
•9) Pregnancy or breastfeeding.

发起方

Department of Thoracic Oncology, National Cancer Center Hospital East