Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Conditions
Keywords
Recurrent and/or Metastatic Nasopharyngeal Carcinoma (NPC)
Brief 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.
Interventions
DRUGFamitinib
25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Sponsors
Sun Yat-sen University
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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 \< 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CBR(Clinical Benefit Rate) | 12 weeks | To evaluate the efficacy (clinical benefit rate) of single-agent famitinib in patients with recurrent or metastatic NPC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS(Progress Free Survival) | 3 years | — |
| DCR(Disease Control Rate) | 12 weeks | — |
| ORR (Objective Response Rate) | 12 weeks | — |
| To evaluate the safety and tolerability | 3 years | Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with Famitinib. |
| QoL(Quality of Life) | 3 years | — |
| OS(Sverall Survival) | 3 years | — |
Countries
China
Outcome results
None listed