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


ABSTRACT: 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.

DISEASE(S): Colorectal Neoplasms Malignant,Colorectal Cancer

PROVIDER: 2533488 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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