famitinib in treating patients with recurrent and/or metastatic nasopharyngeal carcinoma (npc)

Conditions: Recurrent Nasopharyngeal Carcinoma; Metastatic Nasopharyngeal Carcinoma

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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 \ 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. exclusion criteria: * 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.

Keywords: recurrent and/or metastatic nasopharyngeal carcinoma (npc)