EUCTR2008-001605-42-BE进行中（未招募）1 期
A Multicenter, Double-Blind, 3-Arm, Phase 1b/2 Study in Subjects with UnresectableLocally 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
适应症
试验速览
- 阶段
- 1 期
- 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
- •Inclusion Criteria
- •4.1.1 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
- •4.1.2 Demographic
- •Male or female = 18 years of age
- •4.1.3 Ethical
- •Before any study-specific procedure, the appropriate written informed consent
- •must be obtained (see Section 12.1)
- •4.1.4 Laboratory
- •Hemoglobin = 9 g/dL (can be post-transfusion)
- •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/minute (calculated or measured)
- •Aspartate aminotransferase (AST) and alanine amino transferase (ALT) = 2.5 x
- •ULN (OR AST and ALT = 5.0 x ULN in the presence of liver metastasis)
- •Total bilirubin = 1.5x ULN
- •Partial thromboplastin time (PTT) = 1.5 x ULN and international normalized ratio
- •(INR) = ULN
- •4.1.5 General
- •Plan to begin protocol specific therapy within 7 days after enrollment or
- •randomization
- •Able to tolerate infusions and take oral medications
- •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 88
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •Exclusion Criteria
- •4.2.1 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 doses to be administered in this trial.
- •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
- •Known peripheral neuropathy > grade 1
- •Known dihydropyrimidine dehydrogenase deficiency (DPD)
- •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
- •History of any medical condition that in the opinion of the investigator, may
- •increase the risks associated with study participation or study treatments or may
- •interfere with the conduct of the study or interpretation of study results
- •Major surgical procedure = 30 days before enrollment or randomization or not yet
- •recovered from prior major surgery
- •Minor surgery (e,g. catheter or gastrostomy tube placement) =14 days before
- •enrollment or randomization or not yet recovered from prior minor surgery;
- •although placement of central venous access device, fine needle aspiration,
- •thoracentesis, endoscopic biliary stent or paracentesis = 1 day before enrollment
- •or randomization is acceptable
- •Subjects with resectable disease or suitable for definitive chemoradiation
- •Plans for surgical resection based on response to protocol therapy
- •Subjects who have persistent gastric outlet obstruction, complete dysphagia or
- •are dependent upon jejunostomy for feeding.
- •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
- •4.2.2 Cardiac
- •LVEF < 50% as determined by either MUGA scan or ECHO
- •Clinically significant (i.e. active) cardiac disease or myocardial infarction within
- •the last 12 months before enrollment or randomization. Patients with any history
- •of clinically significant cardiac failure are excluded from study entry
- •4.2.3 Other abnormal medical conditions
- •Serious or non-healing wound
- •Known positive test for HIV, hepatitis C, chronic or active hepatitis B
- •Presence of peripheral edema > Grade 2
- •Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
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