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

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

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Stomach Cancer
What the trial is testing?
Ramucirumab, Fluorouracil, Capecitabine, Cisplatin
Could I receive a Placebo?
Yes
Enrollment Goal
645
Trial Dates
Jan 20, 2015 - Aug 14, 2020
How long will I be in the trial?
The duration of your participation will depend on the duration of your study treatment, your disease progression, and follow-up visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have a confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma

  • Participant must have adequate organ function

  • Participant must agree to provide a tumor tissue sample

Participants Must Not:

  • Participant must not have received any prior first-line systemic therapy (however, prior adjuvant or neo-adjuvant therapy is permitted)

  • Participant must not have adenocarcinoma of the esophagus

  • Participant must not have human epidermal growth factor receptor 2 (HER2) positive status

  • Participant must not be receiving long term therapy with nonsteroidal anti-inflammatory agents (NSAIDs), however aspirin use at doses up to 325 mg/day is permitted

  • Participant must not have uncontrolled high blood pressure prior to initiating study treatment

  • Female participant must not be pregnant or lactating

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