None listed
Conditions
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically or cytologically confirmed cancer 2. Age 19 years or older on the date of signing the consent form 3. Patients with ECOG performance status 0-2 4. Patients with an expected survival period of >8 weeks. 5. Those with adequate organ function as defined in the following items; - Absolute neutrophil count (ANC) = 1.0 x 109/L (= 1,000 per mm3) - Platelet count = 100 x 109/L (= 100,000 per mm3) - Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). (Gilbert’s syndrome is an exception). - AST (SGOT)/ALT (SGPT) = 2.5 x institutional UNL (= 5x ULN in the presence of liver metastases) - 24-h urine creatinine clearance or eGFR > 40 mL/min 6. For women, negative pregnancy test or non-fertile women defined as follows: - Menopause (cessation of menstruation for more than 1 year without other medical reasons) - Patients who underwent hysterectomy or bilateral tubal ligation or bilateral oophorectomy 7. Women of fertile potential must agree to follow effective contraception (Appendix 1) during the trial period and for at least 6 months after the last dose of the trial drug, and must have a negative result in a urine or serum pregnancy test performed within 14 days prior to the first dose of the trial drug 8. Intolerance to standard therapy or progressive disease 9. Fusion gene or gene amplification confirmed by genomic analysis of ALK or ROS1 or MET and overexpression of ALK or ROS1 or MET protein in tumor tissue confirmed by targeted proteomic analysis described in Appendix 3 10. Presence of measurable lesion on RECIST
Exclusion criteria
Exclusion criteria: 1. As of the first day of administration of this clinical trial drug (Cycle 1 Day 1), the last day of systemic anticancer treatment (including immunotherapy and small molecule targeted therapy) is less than 14 days, the last day of monoclonal antibody administration is less than 28 days, or the last day of nitrosourea/mitomycin C administration is less than 42 days (consent can be obtained and screening tests can be performed even if the period has not elapsed) 2. Patients participating in other anticancer treatment clinical trials 3. Conditions, treatments, or history of subjects that the investigator determines will make it difficult to evaluate the clinical trial results 4. Uncontrolled active infection, symptomatic heart failure, uncontrolled hypertension/unstable angina/arrhythmia, active bleeding tendency, active hepatitis, mental illness or social situation that may interfere with written consent 5. Patients with a history of leptomeningeal metastasis. 6. Patients with uncontrolled brain metastases or spinal cord compression (patients whose symptoms are stable after discontinuation of anticonvulsants at least 14 days before the administration of the clinical trial drug may be enrolled) 7. Uncontrolled seizures 8. Pregnant or potentially pregnant women, lactating women, men who are unwilling to use adequate contraception for 180 days after the end of the clinical trial, or women of childbearing potential 9. Patients who have received inhibitors for the target, including crizotinib 10. Patients on dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive evaluation of CT or MRI results according to RECIST 1.1 criteria, and evaluation of laboratory tests/vital sign abnormalities, adverse reactions, etc. according to NCI CTCAE v5 | — |
Countries
Korea, Republic of
Contacts
Public ContactHye sun Youn
National Cancer Center
Outcome results
None listed