Axitinib as Second-line Treatment for Advanced Hepatocellular Carcinoma
Axitinib can can inhibit the activity of multiple angiogenesis-related signaling pathways.
Promising anti-tumor activity has been demonstrated in patients with renal cell carcinoma,
thyroid cancer, and melanoma. The potent anti-angiogenic activity of axitinib makes it a
promising agent for the treatment of HCC.
This is a single-arm, open-label phase II trial. Eligible patients will receive axitinib,
starting at 5 mg orally twice daily in the fasting status, until objective disease
progression, development of unacceptable toxicity, or voluntary discontinuation. Dose
titration will be done according to the severity of adverse events.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
disease stabilization
8 weeks until tumor progression
Yes
Ann-Lii Cheng, MD, PhD
Principal Investigator
Director/Professor
United States: Food and Drug Administration
201008013M
NCT01273662
April 2011
December 2013
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