Nasopharyngeal Carcinoma (NPC) Axitinib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01249547
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : April 25, 2017
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Recurrent or Metastatic NPC Drug: axitinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Study Start Date : December 2010
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

Arm Intervention/treatment
Experimental: axitinib arm Drug: axitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.

Primary Outcome Measures :
  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. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To assess objective response rate [ Time Frame: 3 years ]
  2. To assess duration of response [ Time Frame: 3 years ]
  3. To assess progression-free survival [ Time Frame: 3 Years ]
  4. To assess overall survival [ Time Frame: 3 Years ]
  5. To evaluate the safety and tolerability of axitinib [ Time Frame: 3 years ]
  6. To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters [ Time Frame: 3 years ]
  7. To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01249547

Hong Kong
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Anthony TC Chan, MD, FRCP Department of Clinical Oncology, The Chinese University of Hong Kong

Responsible Party: CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong Identifier: NCT01249547     History of Changes
Other Study ID Numbers: NPC022
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: March 2017

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