Nasopharyngeal Carcinoma (NPC) Axitinib

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Axitinib

Criteria

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.