Nasopharyngeal Carcinoma (NPC) Axitinib

Recurrent or Metastatic NPC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249547
• Other study ID #: NPC022
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2010
• Last updated: April 24, 2017
• Start date: December 2010
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms
• Recurrent or Metastatic NPC

Intervention

Drug:
• axitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Locations

Country	Name	City	State
Hong Kong	Department of Clinical Oncology, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To assess objective response rate		3 years
Secondary	To assess duration of response		3 years
Secondary	To assess progression-free survival		3 Years
Secondary	To assess overall survival		3 Years
Secondary	To evaluate the safety and tolerability of axitinib		3 years
Secondary	To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters		3 years
Secondary	To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes		3 years