EUCTR2014-003850-15-AT进行中（未招募）1 期
A phase II, multicenter, study of oral cMET inhibitor INC280 in adult patients with EGFR wild-type (wt), advanced non-small cell lung cancer (NSCLC) - Study of oral cMET inhibitor INC280 in patients with EGFR wild-type, advanced NSCLC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 456
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.Age = 18 years 2. Stage IIIB or IV NSCLC (any histology) at the time of study entry 3.Histologically or cytologically confirmed diagnosis of NSCLC that is:
- •a.EGFR wild-type. This should have been assessed as part of the patient standard of care by a validated test for EGFR mutations, as per the Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors (Lindeman et al 2013), b.AND ALK-negative rearrangement. This should have been assessed as part of the patient standard of care by a validated test, c.AND (as determined by central assessment at a Novartis designated laboratory) either: Cohort 1: Patients with cMET GCN = 6, including: Sub-cohort 1a: Patients with cMET GCN of =10, or Sub-cohort 1b: Patients with cMET GCN of = 6 and < 10, or Cohort 2: Patients with cMET GCN = 4 and < 6, or Cohort 3: Patients with cMET GCN < 4, or Cohort 4: Patients with cMET mutation regardless of cMET GCN or Cohort 5 : Patients treatment-naïve
- •with cMET dysregulation for advanced/metastatic disease in 2 Subcohorts (5a - patients with cMET GCN of =10 or 5b - patients with cMET mutations regardless of cMET GCN) or cohort 6 Pre-treated patients with
- •either cMET GCN = 10 without cMET mutations or cMET mutations regardless of cMET GCN or cohort 7 treatment naïve patients with cMET mutations regardless of cMET GCN.
- •4.To be eligible in cohort 1 to 4 : Patients must have failed one or two prior lines of systemic therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). To be eligible in cohort 6 patients must have failed
- •one prior line of systemic therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). To be eligible in cohort 5 : patients must not have received any systemic therapy for advanced/metastatic disease (stage IIIB or IV NSCLC). To be eligible in cohort 5 and cohort 7 : patients must not have received any systemic therapy for advanced/metastatic disease.
- •5.At least one measurable lesion as defined by RECIST 1.1.
- •6.Patients must have recovered from all toxicities related to prior anticancer therapies to grade = 1 (CTCAE v 4.03). Patients with any grade of alopecia are allowed to enter the study.
- •7.Patients must have adequate organ function including the following laboratory values at the screening visit: Absolute neutrophil count (ANC) = 1.5 x 109/L without growth factor support; Platelets = 75 x 109/L; Hemoglobin (Hgb) > 9 g/dL; Calculated creatinine clearance (using Cockcroft-Gault formula) = 45 mL/min; Total bilirubin = 1.5 x ULN; Aspartate transaminase (AST) = 3 x ULN, except for patients with liver metastasis, who may only be included if AST = 5 x ULN; Alanine transaminase (ALT) = 3 x ULN, except for patients with liver metastasis, who may only be included if ALT = 5 x ULN; Alkaline phosphatase (ALP) = 5 x ULN; Asymptomatic serum amylase = grade 2. Patients with grade 1 or grade 2 serum amylase at the beginning of the study must be confirmed to have no signs and/or symptoms suggesting pancreatitis or pancreatic injury (e.g., elevated P-amylase, abnormal imaging findings of pancreas, etc.); Serum lipase = ULN; Fasting plasma glucose = 175 mg/dL (= 9.7 mmol/L). Patients must have the following laboratory values within the laboratory normal limits or corrected to within normal limits with supplements during screening: Potassium; Magnesium;
- •Phosphorus; Total calcium (corrected for serum albumin). ECOG performance status (PS) of 0 or 1. Please refer to protocol for further d
排除标准
- •1. Prior treatment with crizotinib, or any other cMET or HGF inhibitor
- •2. Patients with known hypersensitivity to any of the excipients of
- •3. Patients with characterized EGFR mutations that predict sensitivity to
- •EGFR therapy, including, but not limited to exon 19 deletions and exon
- •21 mutations.
- •4. Patients with characterized ALK-positive rearrangement
- •5. Patients with symptomatic central nervous system (CNS) metastases
- •who are neurologically unstable or have required increasing doses of
- •steroids within the 2 weeks prior to study entry to manage CNS
- •6. Presence or history of carcinomatous meningitis
- •7. Presence or history of a malignant disease other than NSCLC that has
- •been diagnosed and/or required therapy within the past 3 years.
- •Exceptions to this exclusion include the following: completely resected
- •basal cell and squamous cell skin cancers, and completely resected
- •carcinoma in situ of any type
- •8. Clinically significant, uncontrolled heart diseases.
- •Unstable angina within 6 months prior to screening
- •Myocardial infarction within 6 months prior to screening
- •History of documented congestive heart failure (New York Heart
- •Association functional classification III-IV)
- •Uncontrolled hypertension defined by a Systolic Blood Pressure
- •(SBP) = 160 mm Hg and/or Diastolic Blood Pressure (DBP) = 100 mm
- •Hg, with or without antihypertensive medication. 9. Thoracic
- •radiotherapy to lung fields = 4 weeks prior to starting INC280 or
- •patients who have not recovered from radiotherapy-related toxicities.
- •For all other anatomic sites (including radiotherapy to thoracic vertebrae
- •and ribs), radiotherapy = 2 weeks prior to starting INC280 or patients
- •who have not recovered from radiotherapy-related toxicities. Palliative
- •radiotherapy for bone lesions = 2 weeks prior to starting INC280 is
- •10. Major surgery (e.g., intra-thoracic, intra-abdominal or intra-pelvic)
- •within 4 weeks prior (2 weeks for resection of brain metastases) to
- •starting INC280 or who have not recovered from side effects of such
- •11. Patients receiving treatment with medications that meet one of the
- •following criteria and that cannot be discontinued at least 1 week prior
- •to the start of treatment with INC280 and for the duration of the study:
- •Strong inducers of CYP3A4
- •12. Impairment of GI function or GI disease that may significantly alter
- •the absorption of INC280
- •13. Unable or unwilling to swallow tablets as per dosing schedule
- •14. Patients receiving unstable or increasing doses of corticosteroids. If
- •patients are on corticosteroids for endocrine deficiencies or tumorassociated
- •symptoms other than CNS related, dose must have been
- •stabilized (or decreasing) for at least 5 days before first dose of INC280
- •15. Patients receiving treatment with any enzyme-inducing
- •anticonvulsant that cannot be discontinued at least 1 week before first
- •dose of INC280, and for the duration of the study. Patients on nonenzyme-
- •inducing anticonvulsants are eligible
- •16. For cohort 1 to 4 and cohort 6 Previous anti-cancer and
- •investigational agents within 4 weeks or = 5 x half-life of the agent
- •(whichever is longer) before first dose of INC280. If previous treatment
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研究者
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