EUCTR2017-004157-16-IT进行中（未招募）1 期
Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation - CABinMET
FONDAZIONE RICERCA TRASLAZIONALE (FORT)0 个研究点目标入组 25 人开始时间: 2021年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Citological or histological diagnosis of NSCLC non-small-cell-lung cancer (NSCLC) stage III B (notn suitable for local treatments with curative intent) or stage IV.
- •2.Tissue samples available for MET analysis (archivial tissue or tissue collected at study entry); patients without archival tumor tissue or refusing new biopsy at study entry, are eligible if MET mutation is detected in cf-DNA
- •3.Presence of MET mutations (exon 14 skipping mutation ONLY) detected in tissue or cf-DNA at the local lab or in the central lab or MET amplification (MET/CEP7 ratio > 2.2) detected in the central lab ONLY.
- •4.Measurable disease according to RECIST criteria version 1.1
- •5.At least 1 prior line of standard therapy (chemotherapy and/ or immunotherapy)
- •6.Performance status 0-1 (ECOG)
- •7.Age =18 years
- •8. Patients potentially fertile using adequate methods of contraception in order to avoid childbearing. Contraceptive methods must be respected by male and female patients and their partners during study treatment period and at least 4 months after completing therapy
- •9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment: 7.a. ANC = 1500 cells/µL without granulocyte colony-stimulating factor support 8.b. Platelet count = 100,000/µL without transfusion 9.c. Hemoglobin = 9.0 g/dL
- •Patients may be transfused to meet this criterion
- •d. AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions:
- •- Patients with documented liver metastases: AST and/or ALT = 5 × ULN
- •Patients with documented liver or bone metastases: alkaline phosphatase = 5 × ULN.
- •e. Serum bilirubin = 1.25 × ULN
- •f. Patients with known Gilbert disease who have serum bilirubin level = 3 × ULN may be enrolled
- •g. Calculated creatinine clearance (CRCL) = 45 mL/min or, if using cisplatin, calculated CRCL must be = 60 mL/min
- •10.Patient compliance to the study procedure
- •11.Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1.Tissue sample not available in patients without MET exon 14 skipping mutation detected in cf-DNA
- •2.No possibility to assess MET status
- •3.Absence of any measurable disease according to RECIST criteria
- •4.Co-existence of driver events, including EGFR mutations, KRAS mutations, ALK rearrangements or ROS-1 rearrangements
- •5.No prior therapy
- •6.Concomitant chemotherapy or immunotherapy or radiotherapy
- •7.Symptomatic brain metastasis
- •8.Uncontrolled significant inter-current or recent illness, including cardio-vascular disorders and gastro-intestinal disorders
- •9.Major surgery within 2 months before first dose of study treatment
- •10.Concomitant anti-coagulation with oral anti-coagulants or plated inhibitors
- •11.History of significant bleeding, trachea-bronchial tree/major blood vessels invading tumors, cavity pulmonary lesions and GI disorders associated with a risk of perforation or fistula formation
- •12.Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basalioid)
- •13.Pregnancy or breastfeeding
研究者
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