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A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab,Oxaliplatin, and a Fluoropyrimidine

ABSTRACT: Intervention name : Ramucirumab Dosage And administration of the intervention : Either ramucirumab DP (8 mg/kg) or placebo (a volume equivalent to that of ramucirumab DP), administered as an IV infusion over 60 (+10) minutes on Day 1 of each cycle; then a 1-hour observation period following the initial and second infusions of investigational product; followed by the FOLFIRI regimen indicated in the following bullets Intervention name : Irinotecan (IRI) Dosage And administration of the intervention : 180 mg/m2 administered intravenously over 90 (±10) minutes, 1 hour after the end of the infusion of investigational product (or immediately after the infusion of investigational product if no observation period is required) on Day 1 of each cycle; followed by Intervention name : Folinic acid (FA) Dosage And administration of the intervention : 400 mg/m2 administered intravenously over 120 (±10) minutes on Day 1 of each cycle; followed by Intervention name : 5-Fluorouracil (5-FU) Dosage And administration of the intervention : 400 mg/m2 bolus over 2 to 4 minutes administered intravenously immediately following completion of the FA infusion on Day 1 of each cycle; followed by 5-Fluorouracil (5-FU): 2400 mg/m2 administered intravenously over 46 to 48 hours (continuously) on Days 1 and 2 of each cycle Control intervention name : null

DISEASE(S): Colorectal Cancer

PROVIDER: 2610580 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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