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Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

NCT00917384 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2019-09-25

Study results available
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Summary

The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.

Conditions

Interventions

BIOLOGICAL

ramucirumab

Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg

DRUG

Placebo

Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks

OTHER

Best Supportive Care (BSC)

BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-07-31
Completion
2015-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Bosnia and Herzegovina
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Egypt
  • Guatemala
  • India
  • Indonesia
  • Italy
  • Lebanon
  • Malta
  • Mexico
  • New Zealand
  • Philippines
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00917384 on ClinicalTrials.gov