EUCTR2008-001605-42-IT进行中（未招募）不适用
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with Unresectable Locally Advanced or Metastatic Gastric or Esophagogastric Junction Adenocarcinoma to Evaluate the Safety and Efficacy of First-line Treatment with Epirubicin, Cisplatin, and Capecitabine(ECX) plus AMG 102 - 20060317
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 138
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
- •Disease Related Pathologically confirmed unresectable locally advanced or metastatic gastric or esophagogastric junction (EGJ) adenocarcinoma; tumors of the distal esophagus within 5 cm of the EGJ are eligible ECOG performance status 0 or 1 Life expectancy ≥ 3 months Demographic Male or female ≥ 18 years of age Ethical Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1) Laboratory Hemoglobin ≥ 9 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L (without transfusion within 14 days before enrollment or randomization) Creatinine clearance ≥ 60 mL/min (calculated or measured) Aspartate aminotransferase (AST) and alanine amino transferase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN) (OR AST and ALT ≤ 5.0 x ULN in the presence of liver metastasis) Total bilirubin ≤ 1.5x ULN PTT ≤ 1.5 x ULN and INR ≤ ULN
- •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
- •Disease Related Previous systemic therapy (chemotherapy or biologic therapy) for locally advanced or metastatic gastric or esophagogastric adenocarcinoma Less than 6 months have elapsed from completion of prior neoadjuvant or adjuvant chemotherapy or chemoradiotherapy. Patients previously treated with anthracyclines must not exceed total cumulative dose of epirubicin of 900 mg/m2 (or equivalent thereof, if a different anthracycline has been administered in the past) including dose(s) to be administered in this trial. Subjects with resectable disease or suitable for definitive chemoradiation Plans for surgical resection based on response to protocol therapy Subjects with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy Tumors of squamous cell histology Treatment with radiotherapy ≤ 14 days before enrollment or randomization Known central nervous system metastases Clinically significant upper gastro-intestinal bleeding ≤ 30 days prior to enrollment or randomization Cardiac Left ventricular ejection fraction (LVEF) < 50% as determined by either Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) Clinically significant (i.e. active) cardiac disease or myocardial infarction within the last 12 months before enrollment or randomization. Subjects with any history of clinically significant cardiac failure are excluded from study entry. Other Abnormal Medical Conditions Major surgery ≤ 30 days before enrollment or randomization Minor surgery (e,g. catheter or gastrostomy tube placement) ≤14 days before enrollment or randomization Known peripheral neuropathy > grade 1 Known dihydropyrimidine dehydrogenase deficiency (DPD) deficiency Any prior or synchronous malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent and having completed all therapy, with no evidence of disease ≤ 5 years before enrollment or randomization Any clinically significant medical condition other than cancer, including cardiovascular disease or chronic obstructive pulmonary disease (COPD), which in the opinion of the investigator would interfere with the safe delivery of study treatment or increase risk of toxicity Known HIV infection, hepatitis C, chronic or active hepatitis B Serious or non-healing wound
研究者
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