Nasopharyngeal Carcinoma (NPC) Axitinib

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.

Study Overview

• Status: Completed
• Conditions: Recurrent or Metastatic NPC
• Intervention / Treatment: Drug: axitinib

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of Clinical Oncology, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: axitinib arm	Drug: axitinib; starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Anthony TC Chan, MD, FRCP, Department of Clinical Oncology, The Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: November 29, 2010
• First Posted (Estimate): November 30, 2010

Study Record Updates

• Last Update Posted (Actual): April 25, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: NPC022