<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2017</study_start_year><data_sharing_plan>IPD Sharing (as of May 2023): Yes
Description: Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).
They can ask all interventional clinical studies:
* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com
Additional information available: Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report</data_sharing_plan><condition>Metastatic Colorectal Cancer</condition><condition>Colorectal Neoplasms</condition><condition>Cancer</condition><disease>Metastatic Colorectal Cancer</disease><disease>Colorectal Neoplasms</disease><disease>Cancer</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2253724</full_dataset_link><location>Russia</location><study_start_month>3</study_start_month><keyword>Colorectal</keyword><keyword>Lonsurf</keyword><keyword>S95005</keyword><keyword>Metastatic</keyword><keyword>Trifluridine + tipiracil hydrochloride (S 95005/TAS-102)</keyword><keyword>Russia</keyword><repository>ECRIN MDR</repository><study_status>Completed</study_status></additional><is_claimable>false</is_claimable><name>Study of Efficacy and Safety of S 95005 (TAS-102) in Patients With Metastatic Colorectal Cancer Who Failed Standard Chemotherapies</name><description>The purpose of this study is to evaluate the efficacy of S 95005 in patients with metastatic colorectal cancer (mCRC) who are refractory or intolerant to standard chemotherapies in terms of Progression-Free Survival rate at 2 months in the Russian population.</description><dates><creation>2017-03-15</creation></dates><accession>2253724</accession><cross_references><ClinicalTrials___gov>NCT03274882</ClinicalTrials___gov><ISRCTN>ISRCTN14228310</ISRCTN></cross_references></HashMap>