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METBEIGE biomarker study

ABSTRACT: Intervention name : Cabozantinib Malate INN of the intervention : Cabozantinib Dosage And administration of the intervention : Cabozantinib (administered in the main study): 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): pharmacogenomics Analyses will be performed of the following parameters using formalin-fixed and paraffin-embedded (FFPE) specimens and freshly frozen specimens prepared from tumor tissue collected for the METBEIGE study (before protocol treatment, before the start of the second cycle, and after discontinuation of protocol treatment) and blood specimens collected at the same time. The results obtained from the analyses will be integrated with clinical data obtained in the METBEIGE study to identify biomarkers of the effectiveness of the protocol treatment. 1)Analysis of cancer-related genetic abnormalities 2)Protein expression analysis 3)RNA expression analysis 4)Analysis of cancer cell lines and organoids 5)Patient-derived Xenografts (PDX) analysis Study Design: exploratory research

DISEASE(S): Colorectal Cancer

PROVIDER: 2611915 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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METBEIGE biomarker study

Project description:Interventions: investigational material(s) Generic name etc : Cabozantinib Malate INN of investigational material : Cabozantinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Cabozantinib (administered in the main study): 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : - Primary outcome(s): pharmacogenomics Analyses will be performed of the following parameters using formalin-fixed and paraffin-embedded (FFPE) specimens and freshly frozen specimens prepared from tumor tissue collected for the METBEIGE study (before protocol treatment, before the start of the second cycle, and after discontinuation of protocol treatment) and blood specimens collected at the same time. The results obtained from the analyses will be integrated with clinical data obtained in the METBEIGE study to identify biomarkers of the effectiveness of the protocol treatment. 1)Analysis of cancer-related genetic abnormalities 2)Protein expression analysis 3)RNA expression analysis 4)Analysis of cancer cell lines and organoids 5)Patient-derived Xenografts (PDX) analysis Study Design: exploratory research

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METBEIGE Study

Project description:Intervention name : Cabozantinib Malate INN of the intervention : Cabozantinib Dosage And administration of the intervention : Cabozantinib: 40 mg or 60 mg, once daily at bedtime, oral, in a 28 day-course. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety, efficacy - Proportion of subjects with DLT (phase 1 part) - Confirmed ORR by investigators’ assessment in patients who received study treatment as 3rd line or later (phase 2 part) Study Design: An open-label, single arm phase I study and an open-label, randomized controlled multicenter phase II study

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DS-Screen

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Project description:Intervention name : S-1 (tegafur + gimeracil + oteracil potassium) INN of the intervention : S-1: tegafur, gimeracil, oteracil potassium Dosage And administration of the intervention : 40-60 mg bid day 1 (evening) - day 15 (morning). Repeat cycles every 3 weeks Intervention name : L-OHP (Oxaliplatin) INN of the intervention : oxaliplatin Dosage And administration of the intervention : 130 mg/m2 IV on day 1. Repeat cycles every 3 weeks Intervention name : BV (Bevacizumab) INN of the intervention : bevacizumab Dosage And administration of the intervention : 7.5 mg/kg IV on day 1. Repeat cycles every 3 weeks Control intervention name : 5-FU (Fluorouracil) INN of the control intervention : fluorouracil Dosage And administration of the control intervention : 400 mg/m2 IV bolus on day 1, followed by 2400 mg/m2 over 46 hours. Repeat cycles every 2 weeks. Control intervention name : l-LV (Levofolinate calcium) INN of the control intervention : folic acid Dosage And administration of the control intervention : 200 mg IV on day 1. Repeat cycles every 2 weeks. Control intervention name : L-OHP (Oxaliplatin) INN of the control intervention : oxaliplatin Dosage And administration of the control intervention : 85 mg/m2 IV on day 1. Repeat cycles every 2 weeks. Control intervention name : BV (Bevacizumab) INN of the control intervention : bevacizumab Dosage And administration of the control intervention : 5 mg/kg IV on day 1. Repeat cycles every 2 weeks. Primary outcome(s): Progression free survival(PFS) Study Design: Randomized, open-label, comparative study

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