Overview

This trial is active, not recruiting.

Condition recurrent or metastatic npc
Treatment axitinib
Phase phase 2
Targets VEGF, PDGF
Sponsor Chinese University of Hong Kong
Start date December 2010
End date December 2016
Trial size 37 participants
Trial identifier NCT01249547, NPC022

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
axitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Principal investigator Anthony TC Chan, MD, FRCP
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Chinese University of Hong Kong.