Ramucirumab Use in Combination With Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma; Temporary Authorization for Use (ATU) in France

January 7, 2025 updated by: Eli Lilly and Company
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the ATU.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • The participant has histologically or cytologically confirmed gastric adenocarcinoma, including gastroesophageal junction (GEJ) adenocarcinoma (Participants with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ.) after prior chemotherapy.
  • Acceptable prior chemotherapy regimens for this protocol are combination chemotherapy regimens that include platinum or fluoropyrimidine components (acceptable prior platinum agents are cisplatin, carboplatin, or oxaliplatin; acceptable prior fluoropyrimidine agents are 5-fluorouracil (5-FU) and capecitabine). Prior trastuzumab use in human epidermal growth factor receptor 2 positive (HER2+) participants is accepted too.
  • The participant is eligible for treatment by chemotherapy and has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.

Exclusion Criteria:

  • Participant has a known allergy to any of the treatment components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimated)

December 4, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15263
  • I4T-FR-JVCS (Other Identifier: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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