EUCTR2008-005964-15-IT进行中（未招募）不适用
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 - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- IMCLONE LLC
- 入组人数
- 615
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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; lymph 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. For the complete list please refer to the Protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The patient has documented 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. For the complete list please refer to the Protocol.
研究者
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A clinical trial to study the effects of IMC-1121B and best supportive care (BSC) versus Placebo and BSC in patients with metastatic gastric or gastroesophageal junction adenocarcinoma following disease progression on first line care.CTRI/2010/091/001245ImClone LLC348
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Study investigating new drug, IMC-1121B, in patients with advanced cancer of the stomach/oesophagus that has grown despite standard chemotherapy (combination of chemotherapy including platinum or fluoropyrimidine). Study has two arms. Patients will be assigned randomly to either arm: Arm1: 2/3 of patients receive IMC-1121B and best supportive care; Arm2: 1/3 receive an inactive substance (placebo) and best supportive care. Neither the patient nor the doctor will know the treatment arm.EUCTR2008-005964-15-CZImClone LLC348
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Study investigating new drug, IMC-1121B, in patients with advanced cancer of the stomach/oesophagus that has grown despite standard chemotherapy (combination of chemotherapy including platinum or fluoropyrimidine). Study has two arms. Patients will be assigned randomly to either arm: Arm1: 2/3 of patients receive IMC-1121B and best supportive care; Arm2: 1/3 receive an inactive substance (placebo) and best supportive care. Neither the patient nor the doctor will know the treatment arm.Metastatic Gastric CancerMedDRA version: 14.1 Level: PT Classification code 10063916 Term: Metastatic gastric cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005964-15-GBImClone LLC355
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Study investigating new drug, IMC-1121B, in patients with advanced cancer of the stomach/oesophagus that has grown despite standard chemotherapy (combination of chemotherapy including platinum or fluoropyrimidine). Study has two arms. Patients will be assigned randomly to either arm: Arm1: 2/3 of patients receive IMC-1121B and best supportive care; Arm2: 1/3 receive an inactive substance (placebo) and best supportive care. Neither the patient nor the doctor will know the treatment arm.Metastatic Gastric CancerMedDRA version: 15.1Level: PTClassification code 10063916Term: Metastatic gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-005964-15-MTImClone LLC355
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Study of IMC-1121B (ramucirumab) with Best Supportive Care in patients with gastric cancer and adenocarcinomaAdenocarcinoma. Gastric cancer.C04.557.470.200.025C04.588.274.476.767C04.557.470.200C04.588.274C04.588.274.476RBR-5f6qjgImClone Systems Incorporated