NCT02874651

Brief Summary

This study will enroll patients with non-metastatic nasopharyngeal carcinoma (NPC) that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. The purpose is to evaluate the survival in these patients treated with apatinib (YN968D1), an inhibitor of vascular endothelial growth factor receptor (phase IIa) and to compare the survival in these patients treated with apatinib versus placebo (phase IIb).

Trial Health

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Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2016

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

August 1, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2020

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2.2 years

First QC Date

August 1, 2016

Last Update Submit

December 25, 2021

Conditions

Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal CarcinomaEB VirusDNAvascular endothecial growth factor receptor inhibitorApatinib

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3 years

Secondary Outcomes (12)

  • overall survival

    5 years

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    2 years

  • Changes in quality of life (QOL) as assessed by EORTC QLQ-C30

    2 years

  • Distance Metastasis Free Survival

    3 years

  • locoregional relapse free survival

    3 years

  • +7 more secondary outcomes

Study Arms (2)

Apatinib

EXPERIMENTAL

In the phase IIb part of this trial, patients in this arm will take oral apatinib until disease progression, intolerable toxicity, death or to a maximum of 2 years.

Drug: Apatinib

Placebo

PLACEBO COMPARATOR

In the phase IIb part of this trial, patients in this arm will take oral placebo until disease progression, intolerable toxicity, death or to a maximum of 2 years.

Drug: Placebo

Interventions

ApatinibDRUG

Patients will take oral apatinib. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.

Also known as: YN968D1
Apatinib
PlaceboDRUG

Patients will take oral placebo. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.

Also known as: Placebo tablet
Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven nasopharyngeal carcinoma, with detectable pretreatment plasma EBV DNA
  • Have detectable plasma EBV DNA at the end of (+/- 1 week) curative radiotherapy or chemoradiotherapy (radiation dose \> 66Gy), determined by the central lab
  • No clinical evidence of persistent loco-regional disease
  • No evidence of distant metastasis, based upon skeletal scintigraphy, chest X-ray examination, and liver ultrasound or other appropriate workup (e.g., CT, MRI or positron emission tomography (PET)/CT\]) within 21 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Anticipated survival \>= 3 months
  • Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3
  • Platelets \> 80,000 cells/mm\^3
  • Hemoglobin \>= 8.0 g/dl (no transfusion within the last 14 days)
  • Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\< 2.5 x institutional ULN
  • Creatinine clearance (CC) \>= 50 ml/min estimated by Cockcroft-Gault formula

You may not qualify if:

  • Patients with stage III-IV disease (American Joint Committee On Cancer/Union for International Cancer Control 7th) and no contraindication to chemotherapy that didn't receive platinum based concurrent chemotherapy during radiation
  • Patients with tumor possibly invaded main vessels (e.g. encasement of the internal jugular artery/vein) at diagnosis; or tumor that, in the judgment of the investigator, likely to invade main vessels and cause life-threatening hemorrhage events during study
  • History of serious hemorrhage events or grade 3 or higher hemorrhage within 4 weeks prior to registration
  • Hypertension that couldn't be well controlled with single medication; unstable angina; angina diagnosed within the last 3 months; myocardial infarction within the last 6 months; cardiac arrhythmia that need long-term medication; grade 2 or higher cardiac dysfunction (NYHA)
  • Proteinuria
  • Coagulation dysfunction or predisposition to hemorrhage; on treatment of anticoagulation medication or vitamin K antagonist; low dose warfarin (1mg po qd) or aspirin (less than 100mg daily) were permitted as long as the international normalized ratio (INR) = \< 1.5
  • Thrombosis within the last 1 year, except cured vein thrombosis related to vein indwelling catheter
  • Unhealed bone fracture or chronic unhealed wound
  • Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
  • Pregnant or lactating women
  • Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during and within 6 months after study
  • Current drug abuse or mentally disabled
  • History of congenital or acquired immune deficiency disease or organ transplantation
  • Major medical illness, which in the investigator's opinion would endanger the patients or interfere with the completion of therapy and follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Affiliated Foshan Hospital of Sun Yat-sen University

Foshan, Guangdong, 528000, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541000, China

Location

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsNasopharyngeal CarcinomaEpstein-Barr Virus Infections

Interventions

apatinib

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Jun Ma, M.D.

    Sun Yat-sen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 22, 2016

Study Start

October 1, 2016

Primary Completion

November 29, 2018

Study Completion

August 27, 2020

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)