Completed

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

I4T-MC-JVCU - ClinicalTrials.gov - NCT02314117

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.
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
Email
Completed

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

I4T-MC-JVCU - ClinicalTrials.gov - NCT02314117

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.
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
Email

Key Requirements

Age :

18+

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Gastroesophageal Junction Cancer (GEJ), Stomach Cancer

What the trial is testing?

Ramucirumab, Capecitabine, Cisplatin, Placebo, 5-Fluorouracil

Could I receive a Placebo?

yes

Enrollment Goal

616

Trial Dates

January 2015 - August 2020

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

18+

Sex

All

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

Trial Summary

Conditions the trial is for

Gastroesophageal Junction Cancer (GEJ), Stomach Cancer

What the trial is testing?

Ramucirumab, Capecitabine, Cisplatin, Placebo, 5-Fluorouracil

Could I receive a Placebo?

yes

Enrollment Goal

616

Trial Dates

January 2015 - August 2020

Trial Phase

3

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Trial Locations

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?