NCT01462474已完成1 期
Phase I Study of Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
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 of mono famitinib has shown that the drug's toxicity is manageable.
PURPOSE: This phase I trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, WHO II or III
- •Newly diagnosed T3-4N1（exception metastatic uni or bil retropharyngeal lymph nodes N1） or any TN2-3(7th UICC/AJCC) locally advanced nasopharyngeal carcinoma
- •18-65 years of age
- •ECOG performance status of 0 or 1
- •Life expectancy of more than 6 months
- •At least one measurable lesion :MRI scan larger than 10 mm in diameter, malignant lymph nodes larger than 10 mm in short axis
- •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
- •Before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •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(internal carotid and jugular vein)
- •Hemoglobin < 90g/L, platelets < 100×10^9/L, neutrophils < 2×10^9/L, total bilirubin ≥ 1.25×the upper limit of normal(ULN), ALT\AST ≥ 1.5x ULN), serum creatine > 1x ULN, creatinine clearance rate < 60ml/min, Cholesterol > 7.75 mmol/L and triglyceride > 3 mmol/L, LVEF: < LLN
- •Hypertensive( more than 140/90 mmHg ), more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥470 ms), or cardiac insufficiency
- •URT: urine protein ≥ ++ and > 1.0 g of 24 h
- •Long-term untreated wounds or fractures
- •PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
- •Before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc
- •Preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range
- •Abuse of Psychiatric drugs or dysphrenia
- •Subject of Viral hepatitis type B or type C
- •Subject of immunodeficiency: HIV positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation
- •With drug CYP3A4 inhibitor, inducer, or substrate
- •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)
Drug: Famitinib
Experimental
干预措施: Cisplatin (Drug)
Drug: Famitinib
Experimental
干预措施: radiation（IMRT） (Radiation)
结局指标
主要结局
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
时间窗: 3 weeks
To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib
次要结局
- ORR (Objective Response Rate)(12 weeks after treatment)
- OS(Overall Survival)(2 years and 3 years)
- DFSR(Disease Free Survival Rate)(2 years and 3 years)
- Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days(2 weeks)
- To measure the changes of serum c-Kit，VEGF，Filt，KDR，and PDGFR(2 years)
- LFRSR(Local Free Recurrence Survival Rate)(2 years and 3 years)
- DFMR(Distant Free Metastases Rate)(2 years and 3 years)
- To identify the tumor's molecular profiles in patients with NPCs(2 years)
研究者
研究点 (1)
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