CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 645 enrolled
Drug / intervention
Ramucirumab +4 moredrug
Likely dose
Not stated in 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/NCT02314117
NCT02314117Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

Eli Lilly and Company·interventional·Posted Dec 10, 2014·Updated Aug 26, 2021

In Brief

A Phase 3 clinical trial evaluating Ramucirumab, Capecitabine, and 3 other interventions for Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 645 participants across 135 sites in 20 countries.

Detailed Summary

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 10, 2014
Enrollment StartJan 20, 2015
Primary CompletionJan 17, 2017
Study CompletionAug 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 11.6 years ago

Interventions

Ramucirumabdrug

Administered IV

Capecitabinedrug

Administered orally

Cisplatindrug

Administered IV

Placebodrug

Administered IV

Fluorouracildrug

Administered IV