alexa Phase II, open-label study of brivanib as second-line therapy in patients with advanced hepatocellular carcinoma.
Gastroenterology

Gastroenterology

Journal of Gastrointestinal & Digestive System

Author(s): Finn RS, Kang YK, Mulcahy M, Polite BN, Lim HY,

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Abstract PURPOSE: Brivanib, a selective dual inhibitor of fibroblast growth factor and VEGF signaling, has recently been shown to have activity as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). This phase II open-label study assessed brivanib as second-line therapy in patients with advanced HCC who had failed prior antiangiogenic treatment. EXPERIMENTAL DESIGN: Brivanib was administered orally at a dose of 800 mg once daily. The primary objectives were tumor response rate, time to response, duration of response, progression-free survival, overall survival (OS), disease control rate, time to progression (TTP), and safety and tolerability. RESULTS: Forty-six patients were treated. Best responses to treatment with brivanib (N = 46 patients) using modified World Health Organization criteria were partial responses for two patients (4.3\%), stable disease for 19 patients (41.3\%), and progressive disease for 19 patients (41.3\%). The tumor response rate was 4.3\%; the disease control rate was 45.7\%. Median OS was 9.79 months. Median TTP as assessed by study investigators following second-line treatment with brivanib was 2.7 months. The most common adverse events were fatigue, decreased appetite, nausea, diarrhea, and hypertension. CONCLUSION: Brivanib had a manageable safety profile and is one of the first agents to show promising antitumor activity in advanced HCC patients treated with prior sorafenib. ©2012 AACR. This article was published in Clin Cancer Res and referenced in Journal of Gastrointestinal & Digestive System

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