<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2020</study_start_year><data_sharing_plan>IPD Sharing (as of January 2023): Yes
Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants’ privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional information available: Study Protocol, Statistical Analysis Plan, Clinical Study Report</data_sharing_plan><condition>Metastatic Colorectal Cancer</condition><condition>Colorectal Neoplasms</condition><condition>Advanced or metastatic colorectal cancer (CRC) which is resistant, refractory, or intolerant to at least 2 prior lines of therapy, that must include all of the following agents: fluoropyrimidine, irinotecan, platinum agent, an anti-epidermal growth factor receptor (EGFR) agent (if clinically indicated), an anti-vascular endothelial growth factor (VEGF) agent (if clinically indicated), an immune checkpoint inhibitor (if clinically indicated), and a BRAF inhibitor (if clinically indicated).</condition><disease>Metastatic Colorectal Cancer</disease><disease>Colorectal Neoplasms</disease><disease>Advanced Or Metastatic Colorectal Cancer (crc) Which Is Resistant, Refractory, Or Intolerant To At Least 2 Prior Lines Of Therapy, That Must Include All Of The Following Agents: Fluoropyrimidine, Irinotecan, Platinum Agent, An Anti-epidermal Growth Factor Receptor (egfr) Agent (if Clinically Indicated), An Anti-vascular Endothelial Growth Factor (vegf) Agent (if Clinically Indicated), An Immune Checkpoint Inhibitor (if Clinically Indicated), And A Braf Inhibitor (if Clinically Indicated).</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2346224</full_dataset_link><location>Belgium</location><location>United States</location><location>Japan</location><location>Poland</location><location>Italy</location><location>United Kingdom</location><location>France</location><location>Spain</location><study_start_month>9</study_start_month><keyword>Patritumab deruxtecan</keyword><keyword>U3-1402</keyword><repository>ECRIN MDR</repository><study_status>Terminated</study_status></additional><is_claimable>false</is_claimable><name>A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer</name><description>This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.</description><dates><creation>2020-09-15</creation></dates><accession>2346224</accession><cross_references><ClinicalTrials___gov>NCT04479436</ClinicalTrials___gov><EU Clinical Trials Register>2019-004418-32</EU Clinical Trials Register><Japan Primary Registries Network>JPRN-jRCT2031200139</Japan Primary Registries Network></cross_references></HashMap>