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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Apatinib

• Registration Number: NCT03213587
• Lead Sponsor: Zhejiang Cancer Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-07
• Last Update Submitted: 2017-07-07
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
apatinib	Apatinib	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
OS (overall survival)	2 years	from the first day of therapy to death or last follow-up
PFS (progression free survival)	2 years	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 ).
QoL(quality of life)	2 years	Changes in quality of life were assessed by EORTC QLQ-C30

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China