{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2014"],"condition":["Malignant neoplasm of colon"],"disease":["Malignant Neoplasm Of Colon"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2563320"],"location":["Argentina","Ukraine","Brazil","Russia","India"],"study_start_month":["3"],"repository":["ECRIN MDR"],"study_status":["Not provided"],"additional_accession":[]},"is_claimable":false,"name":"OPEN LABEL RANDOMIZED BIOEQUIVALENCE STUDY TO EVALUATE THEPHARMACOKINETIC (PK) AND SAFETY PROFILE OF BEVACIZUMABBIOSIMILAR (BEVZ92) IN COMBINATION WITH FOLFOX ORFOLFIRI VERSUS BEVACIZUMAB (AVASTIN) IN COMBINATIONWITH FOLFOX OR FOLFIRI AS FIRST-LINE TREATMENT IN PATIENTSWITH METASTATIC COLORECTAL CANCER (MCRC)","description":"Interventions: BEVZ92 (5 mg/kg) will be administered initially as a 90-minute\ninfusion. If well tolerated, the next infusion will be given over a 60-\nminute period. Thereafter, the drug will be given as a 30-minute IV\ninfusion.\nStudy Design: This is a multicenter, open label, randomized bioequivalence study of\nBEVZ92 (bevacizumab biosimilar) and Avastin with 2 parallel arms\nto compare the PK profile of BEVZ92 and Avastin in combination\nwith FOLFOX (any) or FOLFIRI chemotherapy.\nFOLFOX (any) or FOLFIRI will be chosen as per investigator criteria\nbased on the hospital standard of care.\nA cut off will be made after the cycle 2 achieving for the first 20\npatients (10 per arm) for a Safety Data Review by an Independent Data\nSafety Monitoring Review Board (DSMB) in order to ensure the safety\nof the subjects participant in the study and to ensure the validity of the\ndata. Nevertheless, this DSMB will review safety data on each two\nmonths as regular basis throughout the study.\nRecruitment will continue until reaching the target of 100 patients (88\nevaluable).\nA parallel group design is proposed because a cross-over design is not<","dates":{"creation":"2014-03-15"},"accession":"2563320","cross_references":{"Registro Peruano de Ensayos Clínicos":["PER-076-13"]}}