NCT00917384

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

A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Platinum- or Fluoropyrimidine-Containing Combination Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Placebo-controlled, multicenter Phase 3 study of participants with metastatic gastric cancer \[including adenocarcinomas of the gastroesophageal junction (GEJ)\] and disease progression on standard first-line chemotherapeutic regimens. Participants will be randomized on a 2:1 basis to receive best supportive care plus ramucirumab administered every 2 weeks or best supportive care plus placebo administered every 2 weeks, respectively. Participants will undergo radiographic assessment of disease status every 6 weeks. Participant will be treated until there is evidence of progressive disease, toxicity requiring cessation, withdrawal of consent, or until other withdrawal criteria are met. Approximately 348 participants, with histologically- or cytologically-confirmed, metastatic gastric or GEJ adenocarcinoma, and radiographically measurable disease as defined by the Response Evaluation Criteria in Solid Tumors or evaluable, nonmeasurable disease, will be randomized. Participants will be enrolled from approximately 250 study centers in North America, South America, Central America, Asia, Australia, New Zealand, and Europe.

Conditions

• Gastric Cancer
• Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-07-01
• Completion: 2015-12-01
• First posted: 2009-06-10
• Last updated: 2019-09-25
• Results posted: 2014-10-16

Locations

161 sites across 30 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