None listed
Conditions
Interventions
Drug : Study treatment consists of tepotinib consists tepotinib 500mg once daily per oral as a 3 weekly regimen 500mg/d D1-21 orally.
Sponsors
Chungbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically or cytologically confirmed solid cancers (NSCLC, gastric cancer, colorectal cancer, breast cancer, hepatocellular cancer, head and neck cancer, RCC) 2)Subjects who are not eligible for surgical and/or local-regional therapies or who have progressive disease (PD) after surgical and/or local-regional therapies 3)Subjects who have disease progression or are intolerant to the prior standard treatment for advanced solid cancers 4)A tumor biopsy (excluding fine needle aspiration and cytology samples) is required for determining MET status (a fresh pretreatment tumor biopsy is recommended but archived tumor sample is acceptable). MET+ status, as determined by the central laboratory is defined as c-MET exon 14 skipping mutation (981_1028splice, X1007_splice, X1008_splice, X1009_splice, X1010_splice, X963_splice, X1006_splice, 963_D1010splice, Y1003N, D1010H/N/Y), or c-MET copy number gain (=4.0) in the archival or fresh tumor tissue specimen identified in K-MASTER panel. All genetic findings must be reviewed by the study PI, prior to study entry.). 5)Male or female, 19 years of age or older 6)Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). The target lesion that has received previous local therapy should not be considered as measurable unless clear progression has been documented since the therapy. 7)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 8)Signed and dated informed consent indicating that the subject has been informed of all the pertinent aspects of the trial prior to enrollment 9)Life expectancy judged by the Investigator of at least 3 months
Exclusion criteria
Exclusion criteria: 1)Prior treatment with any agent targeting the HGF/c-MET pathway 2)Prior EGFR therapy for EGFR activating mutant NSCLC 3)Local-regional therapy within 4 weeks prior to Day 1 of trial treatment (e.g., major surgery, radiation therapy [with the exception of palliative radiotherapy (e.g. bone, brain) and radiotherapy administered to superficial lesions], hepatic arterial embolization, transcatheter arterial chemoembolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) NOTE: palliative radiotherapy (e.g. bone, brain) should be within a limited field of radiation and for palliation only; it should be a short course, according to local institutional recommendations, and should be completed at least 7 days prior to the first administration of trial treatment 4)Prior history of organ transplant 5)Laboratory index at baseline: ?Hemoglobin = 8.5 g/dL (without transfusion or growth factor support in the preceding 14 days) ?Neutrophils 3 mg/dL ?Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) ?Renal impairment as evidenced by serum creatinine = 1.5 x ULN, or calculated creatinine clearance (CrCl) 2.3 (in accordance with the guidance that has been modified for Child-Pugh classification) ?Albumin 450 msec) 13)Known human immunodeficiency virus (HIV) infection 14)Subjects who have acute pancreatitis and/or chronic pancreatitis, with elevated lipase and/or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rates | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival | — |
Countries
Korea, Republic of
Contacts
Public ContactKi Hyeong Lee
Chungbuk National University Hospital
Outcome results
None listed