EUCTR2005-001362-14-DE进行中（未招募）不适用
Open-label, single-arm, multicenter phase II study of matuzumab in combination with irinotecan background chemotherapy in subjects with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer that developed progressive disease while on therapy or within 4 weeks after termination of an irinotecan based regimen. - MAURICE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 46
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.Inpatient / Outpatient
- •4.ECOG performance status of = 2 at study entry
- •5.Histologically confirmed adenocarcinoma of the colon or rectum
- •6.Metastatic disease
- •7.Tissue available for EGFR testing and immunohistochemical evidence of tumor EGFR (HER 1) expression
- •8.At least 1 bidimensional measurable lesion (not in an irradiated area) according to the modified WHO criteria
- •9.An irinotecan containing regimen as most recent chemotherapy treatment for at least 6 weeks
- •10.Documented progression by comparison of CT or MRI scans on irinotecan based therapy whereby the time between documentation of progression and the end of last irinotecan treatment cycle should not be longer than 4 weeks
- •11.Last application of prior antitumor therapy = 4 weeks
- •12.Time period from documentation of PD to start of study treatment = 12 weeks
- •13.Adequate liver, bone marrow, and renal function, defined as:·Bilirubin = 1.5´upper reference range·Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) = 2.5´ULN (for subjects with liver metastases ALT/AST = 5 ´ ULN)·Neutrophils > 1500 mm3·Platelets > 100,000/µL·Hemoglobin > 10 g/dL·Serum creatinine = 1.5 x ULN or glomerular filtration rate of > 60 mL/minute
- •14.Recovery from relevant toxicity to previous treatment before study entry
- •15.Willingness to use contraceptive method for the study duration and 2 months post-dosing.
- •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 exposure to epidermal growth factor targeting or epidermal growth factor signaling therapy
- •2.Previous exposure to VEGF targeting or VEGF-signaling therapy
- •3.Radiotherapy or major surgery within the last 30 days prior to the start of study treatment
- •4.Documented or symptomatic brain metastases and/ or central nervous system metastases or leptomeningeal disease
- •5.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
- •6.Known hypersensitivity to matuzumab or irinotecan (according to the current investigators’ brochure for matuzumab and the relevant product information sheets for irinotecan)
- •7.History of acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
- •8.Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias
- •9.Clinically significant abnormal electrocardiogram (ECG) or cardiac history (e.g. subjects with myocardial infarction within the last 6 months)
- •10.Significant disease which, in the Investigator’s opinion, would exclude the subject from the study
- •11.Subject requires concurrent treatment with a non-permitted drug
- •12.Participation in another clinical study within 30 days before first study treatment
- •13.Pregnancy (absence to be confirmed by serum ß-hCG test) or lactation period
- •14.Known alcohol or drug abuse
- •15.Legal incapacity or limited legal capacity
研究者
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