Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Chinese University of Hong Kong1 site in 1 country37 target enrollmentDecember 2010

ConditionsRecurrent or Metastatic NPC

Interventionsaxitinib

Drugsaxitinib

Overview

Phase: Phase 2
Intervention: axitinib
Conditions: Recurrent or Metastatic NPC
Sponsor: Chinese University of Hong Kong
Enrollment: 37
Locations: 1
Primary Endpoint: To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chinese University of Hong Kong

Responsible Party

Principal Investigator

CCTU

Comprehensive Clinical Trial Unit

Chinese University of Hong Kong

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
•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.

Arms & Interventions

axitinib arm

Intervention: axitinib

Outcomes

Primary Outcomes

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

To assess objective response rate(3 years)
To assess duration of response(3 years)
To assess progression-free survival(3 Years)
To assess overall survival(3 Years)
To evaluate the safety and tolerability of axitinib(3 years)
To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters(3 years)
To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes(3 years)