In this article, we will discuss Ramucirumab (20). So, let’s get started.
Clinical Trials Experience
Clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Safety data are presented from two randomized, placebo controlled clinical trials in which patients received Ramucirumab: Study 1, a randomized (2:1), double-blind, clinical trial in which 351 patients received either Ramucirumab 8 mg/kg intravenously every two weeks or placebo every two weeks and Study 2, a double-blind, randomized (1:1) clinical trial in which 656 patients received paclitaxel 80 mg/m2 on days 1, 8, and 15 of each 28-day cycle plus either Ramucirumab
8 mg/kg intravenously every two weeks or placebo every two weeks.
Both trials excluded patients with ECOG performance status of 2 or greater, uncontrolled hypertension, major surgery within 28 days, or patients receiving chronic anti-platelet therapy other than once daily aspirin. Study 1 excluded patients with bilirubin ≥1.5 mg/dL and
Study 2 excluded patients with bilirubin >1.5 times the upper limit of normal.