NCT03180476

Brief Summary

The study is to evaluate the efficacy and safety of Apatinib as maintenace therapy for Nasopharyngeal Carcinoma With Metastasis after Chemoradiotherapy, including progress free survival(PFS)、overall survival (OS)、Quality of life score (QoL) and evaluation of drug safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

June 6, 2017

Last Update Submit

April 13, 2023

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    The first day of treatment to the date that disease progression is reported

    12 months

Secondary Outcomes (2)

  • Overall survival

    up to 24 months

  • Quality of Life (QoL) questionnaire

    up to 24 months

Study Arms (1)

apatinib

EXPERIMENTAL

apatinib,500mg,qd，28 day/cycle until the emergence of PD, death, intolerable toxicity

Drug: Apatinib

Interventions

ApatinibDRUG

Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.

Also known as: YN968D1, apatinib mesylate tablets
apatinib

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged ranging from 18 to 75 years old.
  • Naive or recurrent Nasopharyngeal Carcinoma with metastasis after chemotherapy or radiotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
  • Adequate hematologic (neutrophil count\>=1.5×109/L, hemoglobin\>=80g/L, platelets\>=80×109/L), hepatic function (aspartate transaminase (AST) \& alanine transaminase(ALT) =\<upper normal limit(UNL) x2, bilirubin level =\< UNL x 1.5).
  • Adequate renal function (creatinine clearance ≥ 60 mL/min).
  • Patients have the ability to understand and voluntarily sign the informed consent, and allow adequate follow-up.

You may not qualify if:

  • Previously, patients did receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
  • Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
  • Bleeding tendency or coagulation disorders.
  • with brain metastases.
  • Uncontrolled hypertension (systolic pressure\>150 mmHg , or diastolic pressure\> 90 mmHg).
  • Urine protein≥++, or urine protein in 24 hours≥1.0g
  • Severe uncured wounds, ulcers or fracture.
  • Pregnant or breast-feeding.
  • Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy agents).
  • Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
  • The researcher believe that the Patient is not suitable to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 600000, China

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

apatinib

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Mei Feng

    Sichuan Cancer Hospital and Research Institute

    PRINCIPAL INVESTIGATOR

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
Associate chief physician

Study Record Dates

First Submitted

June 6, 2017

First Posted

June 8, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

CN(1)