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CompletedNCT01249547Updated Apr 25, 2017

Nasopharyngeal Carcinoma (NPC) Axitinib

A Phase 2 interventional study of axitinib in Recurrent or Metastatic NPC, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-25.

Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.

02

Conditions studied

  • Recurrent or Metastatic NPC

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03

In context

Recurrence

4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's enrollment of 37 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.

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Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
  • Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
  • Disease must be not amenable to potentially curative radiotherapy or surgery.
  • Measurable disease according to RECIST.
  • Age 18 or above; ECOG performance 0 or 1.
  • Adequate bone marrow, renal and hepatic reserve.

Exclusion criteria

Exclusion Criteria:

  • Presence of local recurrence
  • Presence of neck lymph node recurrence invading vascular structure;
  • Presence of central lung lesions involving major blood vessels;
  • History of hemoptysis or epistaxis within 4 weeks;
  • Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy;
  • Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome;
  • Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    axitinib arm

    Drug: axitinib

Interventions

  • Drugaxitinib

    starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

06

What researchers measure

Primary outcomes

  1. To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.

    Time frame: 3 years

Secondary outcomes

  1. To assess objective response rate

    Time frame: 3 years

  2. To assess duration of response

    Time frame: 3 years

  3. To assess progression-free survival

    Time frame: 3 Years

  4. To assess overall survival

    Time frame: 3 Years

  5. To evaluate the safety and tolerability of axitinib

    Time frame: 3 years

  6. To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters

    Time frame: 3 years

  7. To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes

    Time frame: 3 years

07

Study locations

1 site
  • Department of Clinical Oncology, Prince of Wales Hospital
    Hong Kong, Hong Kong
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2010, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2010
First posted
Nov 30, 2010
Start
Dec 2010
Primary completionActual
Dec 2016
CompletionActual
Dec 2016
Last update
Apr 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01249547
Lead sponsor
Chinese University of Hong Kong
Responsible party
CCTU (Comprehensive Clinical Trial Unit, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 30, 2010
Start date
Dec 2010
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Apr 25, 2017

Study contacts

Anthony TC Chan, MD, FRCP
principal investigator · Department of Clinical Oncology, The Chinese University of Hong Kong

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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