NCT01392235已完成2 期
A Single-arm, Open, Multicenter, Phase II Study of Famitinib as ≥Third Line Treatment in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- CBR(Clinical Benefit Rate)
研究概览
简要总结
RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the drug's toxicity is manageable.
PURPOSE: This phase II trial is studying how well famitinib works in treating patients with recurrent and/or metastatic NPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
- •Have failed for ≥2 lines of chemotherapy
- •At least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
- •≥ 18 and ≤ 70 years of age
- •ECOG performance scale 0-2
- •Life expectancy of more than 3 months
- •More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors
- •Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, 24-hour urinary protein ≤ 1.0 g total bilirubin < 1.25×the upper limit of normal(ULN), and serum transaminase < 1.5×the ULN (If liver metastases, serum transaminase< 2.5×the ULN), serum creatine ≤ 1x ULN, creatinine clearance rate > 50ml/min, Cholesterol≤7.75 mmol/L and triglyceride≤2.5 x ULN, LVEF: ≥ 50%
- •Patients could provide 4-6 pieces of organization wax or pathological section
- •Female: 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 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. 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 6 months after the last dose of test article.
- •Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR, PDGFR and c-Kit
- •Prior radiotherapy more than 2 courses
- •Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Less than 4 weeks from the last clinical trial
- •Any factors that influence the usage of oral administration
- •Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
- •Imageology shows that tumor lesion less than 5 mm to great vessels
- •Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than cla ss I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia, or cardiac insufficiency
- •URT: urine protein ≥ ++ and > 1.0 g of 24 h
- •Long-term untreated wounds or fractures
- •Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
- •Within 6 months before the first treatment occurrs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
- •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) or low-dose aspirin (between 80mg to 100mg daily) is allowed
- •Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
- •Abuse of Psychiatric drugs or dysphrenia
- •Viral hepatitis type B or type C
- •Immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.
研究组 & 干预措施
Drug: Famitinib
Experimental
干预措施: Famitinib (Drug)
结局指标
主要结局
CBR(Clinical Benefit Rate)
时间窗: 12 weeks
To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC
次要结局
- DCR(Disease Control Rate)(12 weeks)
- To evaluate the safety and tolerability(3 years)
- QoL(Quality of Life)(3 years)
- ORR (Objective Response Rate)(12 weeks)
- PFS(Progress Free Survival)(3 years)
- OS(Sverall Survival)(3 years)
研究者
研究点 (1)
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