Status:
COMPLETED
Nasopharyngeal Carcinoma (NPC) Axitinib
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Recurrent or Metastatic NPC
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01249547
Start Date
December 1 2010
End Date
December 1 2016
Last Update
April 25 2017
Active Locations (1)
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1
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong