Recurrent or Metastatic NPCPhase 2NCT01249547
Nasopharyngeal Carcinoma (NPC) Axitinib
A Phase 2 study testing axitinib in people with Recurrent or Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent or Metastatic NPC
- What is being tested?
- axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- Dec 2010to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong
About this study
Official title: Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
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.
- Conditions
- Recurrent or Metastatic NPC
- Being tested
- axitinib
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
axitinibDrug
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
| Study group | Role | What they receive |
|---|---|---|
| axitinib arm | Experimental | Not described Receives: Drug: axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
Measured: 3 years
Secondary outcomes (7)
To assess objective response rate
Measured: 3 years
To assess duration of response
Measured: 3 years
To assess progression-free survival
Measured: 3 Years
To assess overall survival
Measured: 3 Years
To evaluate the safety and tolerability of axitinib
Measured: 3 years
To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters
Measured: 3 years
To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent or Metastatic NPCStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CCTU, Chinese University of Hong Kong
- Investigators
- Anthony TC Chan, MD, FRCP, Principal investigator, Department of Clinical Oncology, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249547
- Sponsor's protocol ID
- NPC022
- Status last verified
- Mar 2017
- First submitted
- 29 Nov 2010
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01249547
- Acronym / sponsor ID
- NPC022
- Conditions
- Recurrent or Metastatic NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| axitinib arm | Experimental | Drug: axitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| axitinibstarting dose of 5 mg twice daily for 4 consecutive weeks without interruption. | Drug | axitinib arm |
Primary outcome
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
7 secondary outcomes
To assess objective response rate
Time frame: 3 years
To assess duration of response
Time frame: 3 years
To assess progression-free survival
Time frame: 3 Years
To assess overall survival
Time frame: 3 Years
To evaluate the safety and tolerability of axitinib
Time frame: 3 years
To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters
Time frame: 3 years
To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
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Becotatug Vedotin Plus Gemcitabine and a PD-1 Inhibitor in Recurrent or Metastatic Nasopharyngeal Carcinoma
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Not yet recruitingPhase 3
A Study of Anti-PD-1 Antibody With or Without BL-B01D1 as Maintenance Therapy Following Anti-PD-1 Antibody Plus Chemotherapy for the First-line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma (PANKU-NPC02)
Nasopharyngeal Carcinoma (NPC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony TC Chan, MD, FRCP principal investigator
Department of Clinical Oncology, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing axitinib in people with Recurrent or Metastatic NPC, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2017.