NCT02314117

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 645 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Ramucirumab	Administered IV
DRUG	Capecitabine	Administered orally
DRUG	Cisplatin	Administered IV
DRUG	Placebo	Administered IV
DRUG	Fluorouracil	Administered IV

Timeline

• Start date: 2015-01-20
• Primary completion: 2017-01-17
• Completion: 2020-08-14
• First posted: 2014-12-10
• Last updated: 2021-08-26
• Results posted: 2018-05-02

Locations

135 sites across 20 countries: United States, Argentina, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Poland, Puerto Rico, Russia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study