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Phase II, open-label study of brivanib as second-line therapy in patients with advanced hepatocellular carcinoma
Clinical Cancer Research, 01/12/2012
Clinical Article
Finn RS et al. – Brivanib had a manageable safety profile and is one of the first agents to demonstrate promising antitumor activity in advanced HCC patients treated with prior sorafenib.
Methods- Brivanib was administered orally at a dose of 800 mg once daily
- Primary objectives were tumor response rate, time to response, duration of response, progression-free survival, OS , disease control rate, time to progression (TTP), and safety and tolerability
- 46 patients
- Best responses to treatment with brivanib (N = 46 patients) using modified World Health Organization criteria were partial responses for 2 patients (4.3%), stable disease for 19 patients (41.3%), and progressive disease for 19 patients (41.3%)
- 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
- Most common AEs were fatigue, decreased appetite, nausea, diarrhea, and hypertension