NCT02356991暂停2 期
A Randomized,Double-Blind, Placebo-Controlled, Multicenter, Phase II Study of Famitinib in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
The purpose of this study is to evaluate the efficacy and safety profile of Famitinib in patients with Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age: 18-70;
- •2.Advanced (IV phase)non squamous NSCLC confirmed by pathology, with measurable lesions (tumour lesions ≥10mm in longest diameter, malignant lymph nodes ≥15mm in short axis, scanning layer ≤ 5 mm, measurable lesions not received locoregional theraphy ,such as radiotherapy or frozen therapy);
- •3.Previously treated with EGFR inhibitors or chemotherapy,second line or above treatment failure:
- •a.for EGFR wild type, second line or above treatment failure(at least previously treated with platinum-based chemotherapy)
- •b.for EGFR mutation type, third line or above treatment failure(at least previously treated with Platinum-based chemotherapy and EGFR inhibitors)
- •4.ECOG Performance Status of 0 or 1;
- •5.Life expectancy of at least 3 months;
- •6.Damage caused by other anti-tumor therapy has been restored, the nitroso or mitomycin treatment interval ≥ 6 weeks; other cytotoxic drugs, radiotherapy or surgery for ≥ 4 weeks; EGFR molecular targeted drugs for ≥ 2 weeks;
- •7.Participants have inadequate organ and marrow function as defined below:
- •Hemoglobin ≥ 90g/L ( no blood transfusion in 2 weeks)
- •Absolute neutrophil count (ANC) ≥ 1.5×10^9/L
- •PLT ≥ 80×10^9/L
- •Bilirubin < 1.25 × ULN
- •ALT < 2.5 × ULN
- •AST < 2.5 × ULN
- •serum creatinine < 1.25 × ULN, and endogenous Cr clearance > 45 ml/min(Cockcroft-Gault Formula)
- •cholesterol ≤ 1.5×ULN and triglyceride≤ 2.5 × ULN
- •LVEF≥ LLN by Color Doppler Ultrasonography
- •8.Female: Child bearing potential, a negative urine or serum pregnancy test result 7 days before initiating famitinib.All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article;
- •9.Ability to understand and willingness to sign a written informed consent. Good compliance with follow-up visits.
排除标准
- •1.Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (lung cancer including small cell carcinoma and non-small cell hybrid);
- •2.Known brain metastases, spinal cord compression, cancer meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
- •3.Patients with hypertension using combination therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 450ms for male and 470ms for female) and class II cardiac dysfunction,according to NCI-CTC AE 4.0;
- •4.Variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction);
- •5.Coagulation abnormalities (PT or PT-INR > 1.5 ULN, and APTT > 1.5 ULN), bleeding tendency (eg, active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy;
- •6.Distance between tumours lesions and major blood vessels with radiographical evidence (CT or MRI) ≥5mm.
- •7.Pulmonary hemorrhage/ bleeding event ≥ CTCAE gr. 1 （including Hemoptysis≥2.5ml or half teaspoon）within four weeks of the first dose of the study drug; Any other hemorrhage/ bleeding event ≥ CTCAE gr. 2 within four weeks of the first dose of the study drug;
- •8.Long-term untreated wounds or fractures;
- •9.Thrombotic or embolic venous or arterial events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 12 months prior to the first dose of study drug;
- •10.Urine protein ≥ + + and confirmed the 24-hour urinary protein>1.0 g;
- •11.Application of anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues; If the prothrombin time international normalized ratio (INR) ≤ 1.5, with the purpose of prevention, the use of small doses of warfarin (1mg orally, once daily) ，low-dose heparin (0.6~1.2 ×10^8 U daily) low-dose aspirin (less than 100mg daily) is allowed;
- •12.Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range;
- •13.Pre-existing ascites and/or clinically significant pleural effusion;
- •14.Active hepatitis C and/or B infection;
- •15.Abuse of psychiatric drugs or dysphrenia;
- •16.Participated in other anti-cancer clinical trials within four weeks;
- •17.Prior therapy with VEGFR inhibitor，except Bevacizumab (Avastin);
- •18.Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
干预措施: Placebo (Drug)
Famitinib
Experimental
Famitinib 25 mg qd p.o., 4 weeks per cycle.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent.
干预措施: Famitinib (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: 1.5 years
次要结局
- Disease Control Rate (DCR)(1 years)
- Overall Survival (OS)(2 years)
- Objective Response Rate (ORR)(1 years)
- Quality of Life(28-day cycle visit until disease progress)
研究者
研究点 (2)
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