Nasopharyngeal Carcinoma (NPC) Axitinib

Phase 2

Completed

• Conditions: Recurrent or Metastatic NPC
• Interventions: Drug: axitinib

• Registration Number: NCT01249547
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-11-29
• Study First Posted: 2010-11-30
• Study Start: 2010-12
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
axitinib arm	axitinib	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong