About the Phase 2 TrialThe 122 patients enrolled in this trial (US n=67; Russia n=39; Western Europe n=16) had unresectable CRC, progressed following first-line treatment and had tumors expressing the wild-type form of the KRAS gene. The primary objective of the trial was to assess the contribution of tivantinib to the irinotecan and cetuximab treatment regimen. The primary endpoint of the study was PFS, and secondary objectives included OS and ORR. Patients were randomized to receive tivantinib, 360 milligrams twice daily, plus irinotecan and cetuximab, or placebo plus irinotecan and cetuximab. The trial was conducted by Daiichi Sankyo, the co-developer with ArQule of tivantinib in all regions outside of certain territories in Asia.
|Date:||Friday, January 11, 2013|
|Time:||9:00 a.m. Eastern Time|
|Conference Call Dial-In Numbers|