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

Phase 2
18 Years
Open (Enrolling)
Recurrent or Metastatic NPC

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Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Anthony TC Chan, MD, FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Clinical Oncology, The Chinese University of Hong Kong


Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:




Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Recurrent or Metastatic NPC
  • Carcinoma
  • Nasopharyngeal Neoplasms