None listed
Conditions
Interventions
Patients will be randomized on a 2:1 basis to IMC-1121B por placebo, respectively. Patients in the active-treatment group will receive IMC-1121B, administered via intravenous (I.V.) infusion every 2 w
Sponsors
ImClone LLC,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. The patient has histologically-or cytologically- confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma (patients with adenocarcinoma of the distal esophagus are eligible if the primary tumor involves the GEJ). 2. The patient has metastatic disease or locally recurrent, unresectable disease. • Patients with nonregional lymph node metastases are eligible; lumph node metastases must be measurable as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0.[56]. • Patients with locally-recurrent, unresectable disease are eligible. • For patients who have received prior radiation therapy, measurable or evaluable lesions must be outside the radiation field, or (for lesions within the radiation field) there must be documented progression following radiation therapy. 3. The patient has measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion (≥20 mm with conventional techniques or ≥ 10 mm by spiral CT), as defined by RECIST Version 1.0.[56] examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST 4. The patient has experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy
Exclusion criteria
Exclusion criteria: 1. The patient has document and/or symptomatic brain or leptomeningeal metastases. 2. The patient has experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization. 3. The patient has experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization. 4. The patient has an ongoing or active infection, Symptomatic cpngestive heart failure unstable angina pectoris, symptomatic or poorly controlled cardic arrhythmia, uncontrolled thrombotic or hemorrhagicdisorder, or any other serious uncontrolled medical disorders in the opinion of the investigator. 5. The patient has ongoing or active psychiatric ilness or social situation that would limit compliace with study requirements. 6. The patient has uncontrolled or poorly- controlled hypertension despite standard medical management. 7. The patient has a serius or non healing wound, ulcer, or bone fracture within 28 days prior to randomization. 8. The patient has received chemotherapy, radiotherapy immunotherapy, or targeded therapy for gastric cancer within 2 weeks prior to randomitazocion. 9. The patient has received any invetigational therapy within 30 days prior to randomization. 10. The patient has undergone major surgery within 28 days prior to randomization, or subcutaneus venous access device placement within 7 days prior to randomization.
Outcome results
None listed