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

NCT ID: NCT03213587

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-07-31

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

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

apatinib

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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

Interventions

Apatinib

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

Intervention Type: DRUG

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Xiaozhong

Director,Department of radiation oncology, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Xiaozhong Chen, MD

Role: primary

cxzfyun@sina.com

+86-571-88128202

Other Identifiers

ZJCH-2017-126

Identifier Type: -

Identifier Source: org_study_id