Nasopharyngeal Carcinoma (NPC) Axitinib

NCT01249547 | Completed Phase 2

• 1 other identifier: NPC022
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (7)

• To assess objective response rate

  3 years

• To assess duration of response

  3 years

• To assess progression-free survival

  3 Years

• To assess overall survival

  3 Years

• To evaluate the safety and tolerability of axitinib

  3 years

Study Arms (1)

axitinib arm

EXPERIMENTAL

Drug: axitinib

Interventions

axitinib DRUG

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

axitinib arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Recurrence

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Anthony TC Chan, MD, FRCP

  Department of Clinical Oncology, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comprehensive Clinical Trial Unit

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: November 30, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 25, 2017

Record last verified: 2017-03

Locations

HK (1)