Clinical trial NCT03213587: Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)
Official title: Apatinib in Treating Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Had Failed Prior Platinum Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologic confirmed recurrent and/or metastatic nasopharyngeal carcinoma( NPC )
2. Have failed for ≥1 lines of platinum based chemotherapy
3. At least one measurable lesion according to the RECIST 1.1
4. ≥ 18 and ≤ 65 years of age
5. ECOG performance scale 0-2
6. Life expectancy of more than 3 months
7. 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.
8. Signed and dated informed consent.

Exclusion Criteria:

1. Prior therapy with tyrosine kinase -inhibitor agent targeting at VEGFR and PDGFR
2. Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
3. Any factors that influence the usage of oral administration
4. Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening
5. 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.
6. Within 3 months before the first treatment occurs myocardial infarction, unstable angina pectoris, cardiac angioplasty or stent implantation
7. Within 1 months before the first treatment received surgical operation and the wounds were not healed
8. 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
9. Blood coagulation abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation.
10. 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.)
11. history of organ transplants
12. 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.

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Primary outcomes:
measure: CBR(Clinical Benefit Rate)
timeFrame: 12 weeks
measure: The incidence of Grade 3-4 adverse events
timeFrame: 2 years
Secondary outcomes:
measure: PFS (progression free survival)
timeFrame: 2 years
measure: OS (overall survival)
timeFrame: 2 years
measure: QoL(quality of life)
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
References: