{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2014"],"condition":["Carcinoma metastatico del colon-retto","metastatic colorectal carcinoma (mCRC)","Colorectal neoplasms malignant"],"disease":["Colorectal Neoplasms Malignant","Metastatic Colorectal Carcinoma (mcrc)","Carcinoma Metastatico Del Colon-retto"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2533411"],"location":["Italy"],"study_start_month":["10"],"keyword":["Refametinib","Erbitux"],"repository":["ECRIN MDR"],"study_status":["Ongoing"],"additional_accession":[]},"is_claimable":false,"name":"COMBINATION OF REFAMETINIB AND CETUXIMAB IN METASTATIC COLORECTAL CANCER TO PREVENT RESISTANCE.","description":"Primary objectives: ARES trial seeks to establish whether a double blockade of the EGFR/MAPK pathway, achievable by combining cetuximab with the MEK inhibitor refametinib, could prevent or treat EGFR-directed secondary resistance in metastatic colorectal cancer. for ARES 0: Define the RP2D of refametinib + CET for ARES 1: Shift 35% of the SD patients in the OR category.for ARES 2: Increase Disease Control rate from 15% to 40%\nPrimary endpoints: for ARES 0: DLTs cycle 1 TRAEs by NCI-CTCAE v 4.0for ARES 1: Tumor response by RECIST v1.1for ARES 2: Disease control by RECIST v1.1","dates":{"creation":"2014-10-15"},"accession":"2533411","cross_references":{"EU Clinical Trials Register":["2014-002460-33"]}}