KCT0004498进行中（未招募）未知
A Phase II Study of Tepotinib (MSC2156119J) in Patients with solid cancers harboring c-MET amplification or exon 14 mutation Who Progressed after Standard treatment for Metastatic disease
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 < 1.5 x 109/L
- •?Platelets < 100 x 109/L (without transfusion or growth factor support in the preceding 7 days)
- •?Total bilirubin > 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) < 40 mL/min by Cockroft-Gault formula (24-hour CrCl might be requested by the Investigator for confirmation, if calculated CrCl is < 40 mL/min. In such case, subjects with 24-hour CrCl < 40 mL/min should be excluded)
- •CrCl (mL/min) = [140 – age (year) x weight (kg)] / 72 x serum creatinine (mg/dL) {x 0.85 for female subjects}
- •?International normalized ratio (INR) > 2.3 (in accordance with the guidance that has been modified for Child-Pugh classification)
- •?Albumin < 28 g/L (without transfusion in the preceding 14 days)
- •6)Past or current history of neoplasm other than current cancer, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, node-negative thyroid cancer or other cancer curatively treated and with no evidence of disease for at least 5 years
- •7)Known central nervous system (CNS) or brain metastasis that is either symptomatic or untreated
- •8)Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested products
- •9)Clinically significant gastrointestinal bleeding within 4 weeks prior to Day 1 of trial treatment
- •10)Impaired cardiac function:
- •?Left ventricular ejection fraction <45% on recent echocardiography (Note: a screening left ventricular ejection fraction assessment without history of congestive heart failure is not required unless clinically indicated.)
- •?Serious arrhythmia
- •?Unstable angina pectoris
- •?Congestive heart failure New York Heart Association (NYHA) III and IV
- •?Myocardial infarction within the last 12 months prior to Day 1 of the trial treatment
- •?Symptomatic uncontrolled Pericardial effusion
- •11)Hypertension uncontrolled by standard therapies (not stabilized to = 150/90 mmHg)
- •12)Subject with a family history of long QT syndrome or who take any agent that is known to prolong QT/QTc interval or with a marked prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 msec)
- •13)Known human immunodeficiency virus (HIV) infection
- •14)Subjects who have acute pancreatitis and/or chronic pancreatitis, with elevated lipase and/or
研究者
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