ArQule announces commencement of tivantinib Phase 3 trial ArQule reported the announcement by its partner, Kyowa Hakko Kirin of the initiation of a Phase 3 clinical trial evaluating tivantinib in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy. The trial is a randomized, double-blind placebo-controlled study to compare progression-free survival in patients treated with tivantinib with those treated with placebo. Kyowa Hakko Kirin plans to enroll approximately 160 patients in this study. Pre-clinical data have demonstrated that tivantinib inhibits MET activation in a range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical trials to date, treatment with tivantinib has been generally well tolerated and has shown clinical activity in the tumors studied. Tivantinib has not yet been approved for any indication in any country.