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
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
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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