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NCT Number: NCT01249547

Nasopharyngeal Carcinoma (NPC) Axitinib

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.

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Key information

Conditions

Recurrent or Metastatic NPC Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Clinical Oncology, Prince of Wales Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Axitinib

Drug

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

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.

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Nov 30, 2010
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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