Brivanib (BMS-582664) in advanced solid tumors (AST): Results of a phase II randomized discontinuation trial (RDT).

3079 Background: Brivanib (B) is an oral once daily selective dual inhibitor of FGF and VEGF signaling currently in phase III development for advanced hepatocellular carcinoma and colorectal cancer. An adaptive RDT was performed to assess therapeutic activity in other AST. Methods: Pts aged ≥18 y with unresectable AST and no other treatment options received open label fixed dose B 800 mg qd for a 12-wk lead-in period, after which they were assessed by CT/MRI. Pts with RECIST response continued on open-label B, those with progressive disease (PD) went off study, and those with stable disease (SD) were randomized 1:1 to B or placebo (P), stratified by FGF2 expression (IHC + or -), until PD or unacceptable toxicity. Steering Committee review of initial open-label data was used to stop enrollment in tumor cohorts with activity judged insufficient to justify expansion. The trial specified 70 randomized pts needed to assess the primary endpoint of improved PFS with a HR of 0.5; secondary endpoints included safe...