A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
The aim of this study is to determine if paclitaxel given together with ramucirumab as
second line therapy will prolong overall survival compared to paclitaxel alone.
Approximately 663 patients (at least 18 years) in approximately 200 study centers and in
approximately 30 countries will be randomized with histologically or cytologically confirmed
metastatic gastric or gastroesophageal junction adenocarcinoma. Patients must have received
at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with
or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy
prior to study entry due to disease progression.
Upon registration and completion of screening procedure and reviewing the Inclusion and
Exclusion Criteria eligible patients will be randomized to receive either paclitaxel plus
ramucirumab or paclitaxel plus placebo.
Ramucirumab DP/placebo will be administered i.v. on days 1 and 15 , paclitaxel will be
administered i.v. on days 1, 8 and 15 of a 4 weekly cycle.
Patients will be continuously treated and monitored until radiographic or symptomatic
progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Overall survival time (OS)
Overall survival time is measured as randomization to date of death from any cause.
Approximately 32 months
E-mail: ClinicalTrials@ ImClone.com
Argentina: Ministry of Health
|ImClone Investigational Site||New York, New York 10021|
|ImClone Investigational Site||Bakersfield, California 93309|
|ImClone Investigational Site||Jacksonville, Florida 32207|
|ImClone Investigational Site||Atlanta, Georgia 30318|
|ImClone Investigational Site||Voorhees, New Jersey 08043|
|ImClone Investigational Site||Memphis, Tennessee 38104|
|ImClone Investigational Site||Dallas, Texas 75230|
|ImClone Investigational Site||Honolulu, Hawaii 96813|
|ImClone Investigational Site||Seattle, Washington 98104|
|ImClone Investigational Site||Albuquerque, New Mexico 87131|