<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2009</study_start_year><condition></condition><condition>Malignant neoplasm of colon-C20  Malignant neoplasm of rectum</condition><condition>Advanced Solid Tumors</condition><condition>Malignant neoplasm of colon</condition><condition>Malignant neoplasm of rectum</condition><condition>Neoplasms</condition><disease></disease><disease>Malignant Neoplasm Of Rectum</disease><disease>Malignant Neoplasm Of Colon-c20  Malignant Neoplasm Of Rectum</disease><disease>Advanced Solid Tumors</disease><disease>Malignant Neoplasm Of Colon</disease><disease>Neoplasms</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2089537</full_dataset_link><location>Taiwan</location><study_start_month>11</study_start_month><keyword>RD</keyword><keyword>Biomarker</keyword><keyword>Sorafenib</keyword><keyword>PG</keyword><keyword>PK</keyword><keyword>MTD</keyword><keyword>DLT</keyword><keyword>S1</keyword><repository>ECRIN MDR</repository><study_status>Completed</study_status></additional><is_claimable>false</is_claimable><name>Sorafenib Plus S-1 in Advanced Solid Tumors</name><description>Primary Objective:
1. To define the recommended dose for phase II study of S-1 combined with sorafenib
2. To evaluate the dose-limiting toxicities of the combination therapy
Secondary Objectives:
1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy
2. 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.
3. To determine the changes of biomarkers between pre- and post-treatments.</description><dates><creation>2009-11-15</creation></dates><accession>2089537</accession><cross_references><ClinicalTrials___gov>NCT01128998</ClinicalTrials___gov><Registro Peruano de Ensayos Clínicos>PER-015-10</Registro Peruano de Ensayos Clínicos></cross_references></HashMap>