Nasopharyngeal Carcinoma (NPC) Axitinib

The Chinese University of Hong Kong

Status and phase

Completed

Phase 2

Conditions

Recurrent or Metastatic NPC

Treatments

Drug: axitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT01249547

NPC022

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.