A Phase II Study of AZD2171 in Hepatocellular Carcinoma
I. Assess the progression free survival of patients with locally advanced unresectable or
metastatic hepatocellular carcinoma treated with AZD2171.
I. Determine the toxicity of this drug in these patients. II. Determine, preliminarily, the
efficacy of this drug, in terms of response rate, duration of response, and overall
survival, in these patients.
III. Determine the blood flow changes and vascular permeability of the tumor in patients
treated with this drug.
IV. Determine the pharmacokinetic profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity. Dynamic contrast-enhanced (DCE) MRI
and CT perfusion scan of the liver are performed at baseline, 72 hours after the initial
dose of AZD2171, and at the end of course 1. Blood samples for pharmacokinetic studies are
collected periodically during study.
After the completion of study treatment, patients are followed every 3 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
This design yields at least 90% power to detect a true 3-month PFS rate of at least 69%.
Massachusetts General Hospital
United States: Food and Drug Administration
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