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Nasopharyngeal NeoplasmsPhase 2ADVANCENCT02874651

ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy

A Phase 2 study testing Apatinib in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Neoplasms
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
3 sitesChina
Study dates
Oct 2016to 27 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Affiliated Foshan Hospital of Sun Yat-sen University

    Foshan, Guangdong, 528000

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541000

Other trials in China

About this study

Official title: ADjuVant Apatinib in Nasopharyngeal Carcinoma Patients With Residual Epstein-Barr Virus (EBV) DNA Following Radiotherapy With or Without Chemotherapy

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).

Read the detailed description

This study has two parts. In the single arm phase IIa part, we will enroll 25 patients that have residual Epstein-Barr virus (EBV) DNA after curative radiotherapy or chemoradiotherapy. All patients will receive apatinib. The purpose is to evaluate the disease free-survival (DFS) in these patients treated with apatinib. In the phase IIb part, patients will be randomized to apatinib or placebo in a ratio of 1:1. The estimated sample size is 78 in phase IIb. However, the final sample size in phase IIb will be determined based on results of the phase IIa part.

Being tested
Apatinib, Placebo
Keywords
Nasopharyngeal Carcinoma, EB Virus, DNA, vascular endothecial growth factor receptor inhibitor, Apatinib
Medical subject headings
Nasopharyngeal Neoplasms, Nasopharyngeal Carcinoma, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApatinibDrug

    Also called YN968D1

    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.

  • PlaceboDrug

    Also called Placebo tablet

    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.

Study groups in NCT02874651
Study groupRoleWhat they receive
ApatinibExperimentalIn 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.
Receives: Drug: Apatinib
PlaceboPlacebo comparatorIn 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Measured: 3 years

Secondary outcomes (12)

  1. overall survival

    Measured: 5 years

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

    Measured: 2 years

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

    Measured: 2 years

  4. Distance Metastasis Free Survival

    Measured: 3 years

  5. locoregional relapse free survival

    Measured: 3 years

  6. Correlation of plasma EBV DNA load with the effect of apatinib on survival

    Measured: 3 years

  7. Correlation of pretreatment serum VEGF level with the effect of apatinib on survival

    Measured: 3 years

  8. Correlation of pretreatment serum VEGFR-2 level with the effect of apatinib on survival

    Measured: 3 years

  9. Correlation of adverse event (hypertension) with the effect of apatinib on survival

    Measured: 3 years

  10. Correlation of adverse event (hand-foot syndrome) with the effect of apatinib on survival

    Measured: 3 years

  11. Correlation of the change from baseline in serum VEGF level at 4 weeks with the effect of apatinib on survival

    Measured: 3 years

  12. Correlation of the change from baseline in serum VEGFR-2 level at 4 weeks with the effect of apatinib on survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study startOct 2016
  3. Primary completion29 Nov 2018
  4. Study completion27 Aug 2020

Why it stopped: Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02874651
Sponsor's protocol ID
Ahead-N301
Acronym
ADVANCE
Status last verified
Dec 2021
First submitted
1 Aug 2016
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Unacceptable toxicity (nasopharynx necrosis and massive hemorrhage)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02874651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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