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Nasopharyngeal Carcinoma (NPC) Axitinib

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Chinese University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01249547
First received: November 29, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Recurrent or Metastatic NPC
Drug: axitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess progression-free survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • To assess overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of axitinib [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: axitinib arm Drug: axitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249547

Contacts
Contact: Anthony TC Chan, MD, FRCP 26322119 anthonytcchan@cuhk.edu.hk
Contact: Rosalie HO, RN 26321135 rosalie@clo.cuhk.edu.hk

Locations
Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Anthony TC Chan, MD, FRCP    2632 2119    anthonytcchan@cuhk.edu.hk   
Contact: Rosalie HO, RN    2632 1135    rosalie@clo.cuhk.edu.hk   
Principal Investigator: Edwin Hui, FRCP         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01249547     History of Changes
Other Study ID Numbers: NPC022
Study First Received: November 29, 2010
Last Updated: June 11, 2014
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Site
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Axitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014