Nasopharyngeal Carcinoma (NPC) Axitinib

NCT ID: NCT01249547

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-12-31

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 based chemotherapy.

Conditions

Recurrent or Metastatic NPC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

axitinib arm

Group Type: EXPERIMENTAL

axitinib

Intervention Type: DRUG

starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Interventions

axitinib

starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CCTU

Comprehensive Clinical Trial Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony TC Chan, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Oncology, The Chinese University of Hong Kong

Locations

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

NPC022

Identifier Type: -

Identifier Source: org_study_id