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.

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.