A Phase II Study of GW786034 (Pazopanib) in Asian Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
OBJECTIVES:
- Determine the efficacy of pazopanib hydrochloride in patients with stage IV or
recurrent nasopharyngeal carcinoma.
- Determine the progression-free survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on angiogenesis inhibition using dynamic
contrast-enhanced CT scan.
- Determine the pharmacokinetic profile of this drug in these patients.
- Correlate the effect of this drug on angiogenesis inhibition with the clinical benefit
rate and pharmacokinetics.
OUTLINE: Patients receive oral pazopanib hydrochloride once daily on days 1-21. Courses
repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection periodically during study treatment for
pharmacokinetic studies. Patients also undergo dynamic contrast-enhanced (DCE) CT scan at
baseline and on days 2 and 29 to document the antiangiogenic effect of pazopanib
hydrochloride and explore the use of DCE CT scan as a surrogate marker of response.
After completion of study treatment, patients are followed periodically for up to 12 months.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate as defined by RECIST criteria (complete response, partial response, or stable disease)
No
Darren L. Wan Teck, MD
Study Chair
National Cancer Centre, Singapore
United States: Food and Drug Administration
CTRG-NP05/25/06
NCT00454142
June 2006
December 2012
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