EUCTR2005-000146-36-ES进行中（未招募）1 期
Randomized Phase II open-label controlled study of EMD 72000 (matuzumab) in combination with the chemotherapy regimen ECX or the chemotherapy regimen ECX alone as first-line treatment in subjects with metastatic esophago-gastric adenocarcinoma - MATRIX E.G.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
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.Written informed consent provided prior to any prescreening procedure
- •2.Male or female, 18 years or older
- •3.Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus
- •4.Metastatic disease
- •5.Normal cardiac function (left ventricular ejection fraction within the institutional normal range)
- •6.At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7.2.2.
- •7.Archived tissue available for EGFR testing and immunohistochemical evidence of tumor EGFR (HER-1) expression in the most recent available sample
- •8.ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- •9.Life-expectancy > 12 weeks
- •10.Adequate liver, bone marrow, and renal function, defined as:
- •Bilirubin < 1.5 x upper limit of normal (ULN)
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 2.5 x ULN (for subjects with liver metastases ALT/AST < 5 x ULN)
- •Neutrophils > 1500 mm3
- •Platelets > 100 000/µl
- •Hemoglobin > 10g/dl
- •Serum creatinine < 1.5 x ULN or glomerular filtration rate (GFR) of =? 60 ml/minute. The GFR is to be based upon the Cockroft-Gault formula for creatinine clearance:
- •GFR (ml/min) = c x (140 – age [years]) x weight (kg)
- •72 x serum creatinine (mg/100 ml)
- •where c = 0.85 for female subjects and c = 1.00 for male subjects
- •11.If of childbearing potential, willingness to use effective contraceptive method for the study duration and 2 months post-dosing. [Females of childbearing potential are defined as any females who have experienced menarche and have not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy), or are not post menopausal (defined as age-related amenorrhea for =12 consecutive months)]
- •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
- •1.Previous chemotherapy
- •2.Radiotherapy or major surgery within the last 4 weeks prior to the start of study treatment
- •3.Prior treatment with an EGFR signal transduction directed therapy
- •4.Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias
- •5.Clinically significantly abnormal electrocardiogram (ECG) or cardiac history (e.g. subjects with myocardial infarction within the last 6 months)
- •6.Treatment with non-permitted medication (as specified in Section 6.8).
- •7.Documented or symptomatic brain metastases and/or central nervous system metastases or leptomeningeal disease.
- •8.Superior vena cava syndrome contra-indicating hydration
- •9.Symptomatic peripheral neuropathy NCI-CTCAE grade =2 and/or ototoxicity grade =2, except if due to trauma or mechanical impairment due to tumor mass
- •10.Known active, uncontrolled infections, uncontrolled severe organ dysfunction or metabolic disorder or any other significant disease which in the investigator’s opinion would exclude the subject from the study
- •11.Pregnancy (confirmed by ß-HCG) or lactation period
- •12.Known hypersensitivity to matuzumab or any of the components of ECX (according to the current investigators’ brochure for matuzumab and the relevant product information sheets for epirubicin, cisplatin and capecitabine)
- •13.Known conditions that would interfere with treatment with any of the substances used in this study
- •14.Participation in another clinical study within the past 30 days
- •15.Concurrent malignancies or invasive cancers diagnosed within the past 5 years, except for: adequately treated basal cell cancer of the skin or in situ cancer of the cervix
- •16.Legal incapacity or limited legal capacity
研究者
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