Active not recruiting

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

I4T-JE-JVCW - ClinicalTrials.gov - NCT02539225

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.
How long will I be in the trial?
Your participation could last up to 54 weeks depending on how you and your tumor respond.
Email
Active not recruiting

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

I4T-JE-JVCW - ClinicalTrials.gov - NCT02539225

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.
How long will I be in the trial?
Your participation could last up to 54 weeks depending on how you and your tumor respond.
Email

Key Requirements

Age :

20+

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

20+

Sex

All

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

Trial Summary

Conditions the trial is for

Stomach Cancer, Gastroesophageal Junction Cancer (GEJ)

What the trial is testing?

Part A: S1/Oxaliplatin + Ramucirumab or S1/Oxaliplatin + Placebo, Part B: Ramucirumab + Paclitaxel

Could I receive a Placebo?

yes

Enrollment Goal

190

Trial Dates

October 2015 - December 2021

Trial Phase

2

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

20+

Sex

All

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

Trial Summary

Conditions the trial is for

Stomach Cancer, Gastroesophageal Junction Cancer (GEJ)

What the trial is testing?

Part A: S1/Oxaliplatin + Ramucirumab or S1/Oxaliplatin + Placebo, Part B: Ramucirumab + Paclitaxel

Could I receive a Placebo?

yes

Enrollment Goal

190

Trial Dates

October 2015 - December 2021

Trial Phase

2

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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?