{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2017"],"data_sharing_plan":["IPD Sharing (as of March 2022): No"],"condition":["Metastatic Colorectal Cancer","Colorectal Neoplasms"],"disease":["Metastatic Colorectal Cancer","Colorectal Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2175119"],"location":["Taiwan"],"study_start_month":["7"],"keyword":["TSB-9-W1"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"To Determine the MTD and to Evaluate the Safety, Efficacy and PK Profiles of TSB-9-W1 in Pre-treated Patients With mCRC.","description":"TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.\n5441947) and Taiwan (Patent No. I432191 and I282280). The R&D laboratory in TSB is ISO/IEC 17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is 2026.The trade name of TSB-9-W1 is \"IDS\" in English, the registration number is 01472800 at 2011 by Intellectual Property Office (IPO), Taiwan.\nA phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal cancer (mCRC).\nthere are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.\nThis is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.\nEach treatment cycle is composed by a contiguous 2-day oral administration and a contiguous 3-day rest. Patient should take the study drug once daily before meal with approximately 250 ml or appropriate amount of water.","dates":{"creation":"2017-07-15"},"accession":"2175119","cross_references":{"ClinicalTrials___gov":["NCT02249650"]}}