{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2009"],"condition":["","Malignant neoplasm of colon-C20  Malignant neoplasm of rectum","Advanced Solid Tumors","Malignant neoplasm of colon","Malignant neoplasm of rectum","Neoplasms"],"disease":["","Malignant Neoplasm Of Rectum","Malignant Neoplasm Of Colon-c20  Malignant Neoplasm Of Rectum","Advanced Solid Tumors","Malignant Neoplasm Of Colon","Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2089537"],"location":["Taiwan"],"study_start_month":["11"],"keyword":["RD","Biomarker","Sorafenib","PG","PK","MTD","DLT","S1"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"Sorafenib Plus S-1 in Advanced Solid Tumors","description":"Primary Objective:\n1. To define the recommended dose for phase II study of S-1 combined with sorafenib\n2. To evaluate the dose-limiting toxicities of the combination therapy\nSecondary Objectives:\n1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy\n2. To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.\n3. To determine the changes of biomarkers between pre- and post-treatments.","dates":{"creation":"2009-11-15"},"accession":"2089537","cross_references":{"ClinicalTrials___gov":["NCT01128998"],"Registro Peruano de Ensayos Clínicos":["PER-015-10"]}}