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METBEIGE Study

ABSTRACT: 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

DISEASE(S): Colorectal Cancer

PROVIDER: 2611903 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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METBEIGE 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: 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 : Dosage and Administration for Investigational material : - 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

| 102460 | ecrin-mdr-crc

A Randomized Phase III Trial of SOX/Bevacizumab versus FOLFOX/Bevacizmab in Treating Patients with Metastatic Colorectal Cancer (SOFT).

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

| 2610116 | ecrin-mdr-crc

METBEIGE biomarker study

Project description: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

| 2611915 | ecrin-mdr-crc

Phase 2 study of DS-8201a in subjects with colorectal cancer [DESTINY-CRC01]

Project description:Intervention name : DS-8201a INN of the intervention : trastuzumab deruxtecan Dosage And administration of the intervention : IV solution (Once every 3 weeks, 6.4 mg/kg) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): efficacy The objective response rate RECIST Version 1.1 Study Design: multi center, open-label, 3-cohort study

| 2658293 | ecrin-mdr-crc

A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer

Project description:Intervention name : OCV-C02 INN of the intervention : - Dosage And administration of the intervention : Once-weekly subcutaneous injection (0.3, 1 3 and 6 mg/body) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety Dose Limiting Toxicity (DLT) Common Terminology Criteria for Adverse Events (CTCAE), ver. 4.0 Study Design: multicenter, open, non-comparative study

| 2657927 | ecrin-mdr-crc

DS-Screen

Project description:Intervention name : - INN of the intervention : - Dosage And administration of the intervention : - Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): exploratory FGFR2 and HER2 protein expression IHC Study Design: Observational study

| 2611525 | ecrin-mdr-crc

ONO-4538/CA2099X8 Phase 2/3 Study(ONO-4538-72/CA2099X8)

Project description:Intervention name : ONO-4538/BMS-936558 INN of the intervention : Nivolumab Dosage And administration of the intervention : Intravenous administration Control intervention name : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab INN of the control intervention : Fluorouracil, Leucovorin Calcium Folinate, Oxaliplatin, Bevacizumab Dosage And administration of the control intervention : Intravenous administration Primary outcome(s): efficacy PFS Study Design: Randomized, open-label

| 2658327 | ecrin-mdr-crc

Phase 1 study of CS-7017 in combination with FOLFIRI

Project description:Intervention name : CS-7017 INN of the intervention : efatutazone Dosage And administration of the intervention : CS-7017(0.25-0.50 mg) administered orally twice a day Control intervention name : null Primary outcome(s): Safety and Pharmacokinetics -To evaluate the safety profile according to CTCAE -To evaluate the pharmacokinetics according to the protocol Study Design: Open Label Phase 1 Study

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A phase I study of TAS-102 and irinotecan

Project description:Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). Control intervention name : irinotecan INN of the control intervention : irinotecan Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

| 2610898 | ecrin-mdr-crc

ONO-7702 and ONO-7703 Expansion Study(ONO-7702/7703-02E)

Project description:Intervention name : Encorafenib, Binimetinib INN of the intervention : encorafenib, binimetinib Dosage And administration of the intervention : Encorafenib will be administered on a QD schedule and binimetinib will be administered on a BID schedule Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - Primary outcome(s): safety, efficacy - Study Design: A Multicenter, Single arm, Open-label Study

| 2612052 | ecrin-mdr-crc

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