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

NCT03213587 | Unknown Phase 2

• 1 other identifier: ZJCH-2017-126
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• CBR(Clinical Benefit Rate)

  The sum rate of complete response, partial response and stable disease

  12 weeks

• 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 Outcomes (3)

• PFS (progression free survival)

  2 years

• OS (overall survival)

  2 years

• QoL(quality of life)

  2 years

Study Arms (1)

apatinib

EXPERIMENTAL

Drug: Apatinib

Interventions

Apatinib DRUG

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

apatinib

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

apatinib

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Department of radiation oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 11, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

CN (1)