Brief Title
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
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
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
CBR(Clinical Benefit Rate)
Secondary Outcome
PFS (progression free survival)
Condition
Nasopharyngeal Carcinoma
Intervention
Apatinib
Study Arms / Comparison Groups
apatinib
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
51
Start Date
July 1, 2017
Completion Date
July 2020
Primary Completion Date
July 2020
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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Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03213587
Organization ID
ZJCH-2017-126
Responsible Party
Principal Investigator
Study Sponsor
Zhejiang Cancer Hospital
Study Sponsor
, ,
Verification Date
July 2017