Gastric Cancer Clinical Trial
Official title:
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
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.
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.
;
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|---|---|---|---|
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