Nasopharyngeal Carcinoma (NPC) Axitinib

Chinese University of Hong Kong37 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent or Metastatic NPC

Interventions

axitinibDRUG

starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

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

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

Data from ClinicalTrials.gov

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