Back to resultsNasopharyngeal Carcinoma (NPC) Axitinib
Primary Purpose
Recurrent or Metastatic NPC
Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
axitinib
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Metastatic NPC
Eligibility Criteria
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:
- 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.
Sites / Locations
- Department of Clinical Oncology, Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
axitinib arm
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
Secondary Outcome Measures
To assess objective response rate
To assess duration of response
To assess progression-free survival
To assess overall survival
To evaluate the safety and tolerability of axitinib
To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters
To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes
Full Information
NCT ID
NCT01249547
First Posted
November 29, 2010
Last Updated
April 24, 2017
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01249547
Brief Title
Nasopharyngeal Carcinoma (NPC) Axitinib
Official Title
Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic NPC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
axitinib arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
axitinib
Intervention Description
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To assess objective response rate
Time Frame
3 years
Title
To assess duration of response
Time Frame
3 years
Title
To assess progression-free survival
Time Frame
3 Years
Title
To assess overall survival
Time Frame
3 Years
Title
To evaluate the safety and tolerability of axitinib
Time Frame
3 years
Title
To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters
Time Frame
3 years
Title
To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony TC Chan, MD, FRCP
Organizational Affiliation
Department of Clinical Oncology, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Oncology, Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Nasopharyngeal Carcinoma (NPC) Axitinib
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