Study of WNT974 in combination with LGX818 and cetuximab in patients with BRAF-mutant metastatic colorectal cancer (mCRC) and Wnt pathway mutations

Primary objectives: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant CRC harboring upstream Wnt pathway mutations.
Phase II: To estimate the preliminary anti-tumor activity of the RP2D(s) of WNT974 in combination with LGX818 and cetuximab in patients with BRAFV600-mutant CRC harboring upstream Wnt pathway mutations
Note:
Further enrollment to the study has been discontinued as of 21 March 2016. Therefore, references to phase II study design and objectives are no longer relevant.
Primary endpoints: 1. Phase Ib: To estimate the MTD(s)/RP2D(s) of the triple combination of WNT974, LGX818 and cetuximab in patients with BRAFV600-mutant, KRAS wild-type (WT) mCRC harboring upstream Wnt pathway mutations, as measured by incidence of dose-limiting toxicities (DLTs) and exposure to WNT974 and LGX818 as measured by PK parameters.
2. Phase II: To estimate the preliminary anti-tumor activity at the RP2D(s) of the combination of WNT974, LGX818 and cetuximab, in patients with BRAFV600-mutant metastatic colorectal cancer harboring upstream Wnt pathway mutations, based on the Overall Response Rate (ORR).
Note: Further enrollment to the study has been discontinued as of 21 March 2016. Therefore, references to phase II study design and objectives are no longer relevant.