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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213587
• Other study ID #: ZJCH-2017-126
• Status: Recruiting
• Phase: Phase 2
• First received: July 3, 2017
• Last updated: July 7, 2017
• Start date: July 1, 2017
• Est. completion date: July 2020

Study information

• Verified date: July 2017
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Apatinib
500 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CBR(Clinical Benefit Rate)	The sum rate of complete response, partial response and stable disease	12 weeks
Primary	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	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
Secondary	OS (overall survival)	from the first day of therapy to death or last follow-up	2 years
Secondary	QoL(quality of life)	Changes in quality of life were assessed by EORTC QLQ-C30	2 years