Patients with advanced non-small cell lung cancer and solid tumors
Conditions
Interventions
investigational material(s)
Generic name etc : AP26113
INN of investigational material : Brigatinib
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : AP261
Sponsors
Department of Thoracic Oncology, National Cancer Center Hospital East
Takeda Pharmaceutical Company Limited.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The objective response rate (ORR) assessed by the Independent Radiology Review (IRR). ORR will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Duration of response (DoR), Disease control rate (DCR) at weeks 8, 16, and 24 after treatment, Progression free survival (PFS), Overall survival (OS), ORR in patients with ROS1-positive advanced solid tumors other than lung cancer, Adverse events (AEs), type/frequency/severity of all laboratory abnormalities, and causal relationship with the study drug, Intracranial ORR (iORR) in patients with measurable central nervous system (CNS) metastases, Intracranial PFS (iPFS) in patients with measurable CNS metastases, As for safety assessment, the incidence of AEs occurring during protocol treatment will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | — |
Countries
Japan
Outcome results
None listed