Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of apatinib in treating patients with recurrent or metastatic nasopharyngeal carcinoma who failed prior platinum based chemotherapy

Official Title
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Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Had Failed Prior Platinum Based Chemotherapy

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Apatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC ) Have failed for ≥1 lines of platinum based chemotherapy At least one measurable lesion according to the RECIST 1.1 ≥ 18 and ≤ 65 years of age ECOG performance scale 0-2 Life expectancy of more than 3 months Adequate hepatic, renal and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 100×10^9/L, neutrophils ≥ 1.5×10^9/L, serum transaminase < 2.5×the upper limit of normal(ULN), (If liver metastases, serum transaminase< 5×the ULN), creatinine clearance rate > 60ml/min. Signed and dated informed consent. Exclusion Criteria: Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR and PDGFR 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 Within 6 months 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. Within 3 months before the first treatment occurs myocardial infarction, unstable angina pectoris, cardiac angioplasty or stent implantation Within 1 months before the first treatment received surgical operation and the wounds were not healed 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 Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation. Preexisting serious accompanying disease which may bring great risk or influence the patient's compliance( uncontrolled hypertension, grade III - IV cardiac insufficiency, severe arrhythmia -QTc duration between 500 m/s, severe liver and kidney insufficiency :urine protein+ +, 24 hours urinary protein > 1.0 g, mental illness.) history of organ transplants 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. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: apatinib<br> | Drug: Apatinib<br>* 500 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CBR(Clinical Benefit Rate) | The sum rate of complete response, partial response and stable disease | 12 weeks | 
| The incidence of Grade 3-4 adverse events | Number of participants with adverse events and serious adverse events.In addition,estimating their relationship with apatinib. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) | from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ). | 2 years | 
| OS (overall survival) | from the first day of therapy to death or last follow-up | 2 years | 
| QoL(quality of life) | Changes in quality of life were assessed by EORTC QLQ-C30 | 2 years |