CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 355 enrolled
Drug / intervention
ramucirumab +2 morebiological
Likely dose
ramucirumab 8 mg/kgfrom 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/NCT00917384
NCT00917384Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy

Eli Lilly and Company·interventional·Posted Jun 10, 2009·Updated Sep 25, 2019

In Brief

A Phase 3 clinical trial evaluating ramucirumab, Placebo, and 1 other intervention for Gastric Cancer and Adenocarcinoma. Completed, enrolled 355 participants across 161 sites in 30 countries.

Detailed Summary

The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Cancer, Adenocarcinoma
CountriesArgentina, Australia, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, Croatia, Czechia, Egypt, Guatemala, India, Indonesia, Italy, Lebanon, Malta, Mexico, New Zealand, Philippines, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2009
Enrollment StartAug 1, 2009
Primary CompletionJul 1, 2012
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.1 years ago

Interventions

ramucirumabbiological

Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg

Placebodrug

Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

Best Supportive Care (BSC)other

BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.