CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 665 enrolled
Drug / intervention
Ramucirumab (IMC-1211B) DP +2 morebiological
Likely dose
Ramucirumab (IMC-1211B) DP 8 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01170663
NCT01170663Phase 3Completed
CompareCT.gov

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

Eli Lilly and Company·interventional·Posted Jul 27, 2010·Updated Sep 18, 2019

In Brief

A Phase 3 clinical trial evaluating Ramucirumab (IMC-1211B) DP, Placebo, and 1 other intervention for Gastric Cancer. Completed, enrolled 665 participants across 167 sites in 26 countries.

Detailed Summary

This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Poland, Portugal, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2013
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.9 years ago

Interventions

Ramucirumab (IMC-1211B) DPbiological

8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle

Placebodrug

Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle

Paclitaxeldrug

Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle