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Brief Title: Study of WNT974 in Combination With LGX818 and Cetuximab in Patients With BRAF-mutant Metastatic Colorectal Cancer (mCRC) and Wnt Pathway Mutations
Official Title: A Phase Ib/II Multi-center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients With BRAFV600-mutant KRAS Wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations
Study ID: NCT02278133
Brief Summary: The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of WNT974, LGX818 and cetuximab in BRAFV600-mutant mCRC with RNF43 mutations or RSPO fusions. The design of this study is based upon the translational and pre-clinical data that suggest that Wnt pathway signals, increased due to RNF43 mutations or RSPO fusions, cooperate with the EGFR and BRAF signals to maintain the growth of BRAFV600 CRCs. Inhibition of these signals with the triple combination of WNT974, LGX818 and cetuximab may result in anti-tumor activity.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Memorial Sloan-Kettering Cancer Center (MSKCC) MSKCC (3), New York, New York, United States
Medical University of South Carolina Oncology Dept, Charleston, South Carolina, United States
University of Texas/MD Anderson Cancer Center Onc. Dept,, Houston, Texas, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc, Madison, Wisconsin, United States
Array BioPharma Investigative Site, Parkville, Victoria, Australia
Array BioPharma Investigative Site, Leuven, , Belgium
Array BioPharma Investigative Site, Edmonton, Alberta, Canada
Array BioPharma Investigative Site, Vancouver, British Columbia, Canada
Array BioPharma Investigative Site, Toronto, Ontario, Canada
Array BioPharma Investigative Site, Bordeaux, , France
Array BioPharma Investigative Site, Marseille, , France
Array BioPharma Investigative Site, Tel-Aviv, , Israel
Array BioPharma Investigative Site, Milano, MI, Italy
Array BioPharma Investigative Site, Amsterdam, , Netherlands
Array BioPharma Investigative Site, Singapore, , Singapore
Array BioPharma Investigative Site, Barcelona, Catalunya, Spain
Array BioPharma Investigative Site, Hospitalet de LLobregat, Catalunya, Spain
Array BioPharma Investigative Site, Madrid, , Spain
Array BioPharma Investigative Site, Madrid, , Spain
Name: Clinical Trial Call Center
Affiliation: Array BioPharma, Inc.
Role: STUDY_DIRECTOR