A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

I4T-JE-JVCW -

The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with or without ramucirumab as first line therapy in participants with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Trial Summary

Age Range
≥20 years
Conditions the trial is for
Stomach Cancer
What the trial is testing?
Ramucirumab, Oxaliplatin, Paclitaxel, S-1
Could I receive a Placebo?
Yes
Enrollment Goal
191
Trial Dates
Oct 5, 2015 - Mar 10, 2021
How long will I be in the trial?
Your participation could last up to 54 weeks depending on how you and your tumor respond.
Trial Phase
II

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 diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, confirmed by histology or cytology; participants with esophageal cancer are not eligible

  • Participants of reproductive potential (men and woman) must agree to use contraception (hormonal or barrier methods) during the study period and at least 6 months after the last dose of study treatment

  • Participant must be willing to provide a blood sample for research purposes

Participants Must Not:

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

  • Participant must not have known brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression

  • Female participant must not be pregnant or breast feeding. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to first dose of study treatment

  • Participant must not have any prior malignancies

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