EUCTR2007-001609-81-DE进行中（未招募）不适用
Phase I/II study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine in patients with advanced pancreatic cancer
Philogen S.pA.0 个研究点目标入组 50 人开始时间: 2007年6月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •?Histologically or cytologically confirmed solid cancer of any pathology or adenocarcinoma of the pancreas with evidence of locally advanced (non resectable Stage II or III) or metastatic disease (Stage IV; Appendix B).
- •?Karnofsky performance status 60-100% for phase 1 and >50 and <80% for phase II (ECOG performance status =2).
- •?Patients aged >=18 years.
- •?Sufficient hematologic, liver and renal function:
- •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
- •?Presence of active infections (e.g. requiring antibiotic therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
- •?Presence of known brain metastases.
- •?Known to have a second uncontrolled cancer of other primary origin within the last 5 years.
- •?Chronic active hepatitis or active autoimmune diseases.
- •?History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris.
- •?Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria).
- •?Irreversible cardiac arrhythmias requiring permanent medication.
- •?Uncontrolled hypertension.
- •?Ischemic peripheral vascular disease (Grade IIb-IV).
- •?Severe rheumatoid arthritis.
- •?Severe diabetic retinopathy.
- •?Recovery from major trauma including surgery within 4 weeks of administration of study treatment.
- •?Known history of allergy to IL2, gemcitabine, or other intravenously administered human proteins/peptides/antibodies.
- •?Chemotherapy (standard or experimental) or radiation therapy within 4 weeks of the administration of study treatment for patients recruited to the phase I part of the study.
- •?Prior chemotherapy or radiation therapy or treatment with an investigational study drug for patients recruited to the fixed-dose part (phase II) of the study.
- •?Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment.
- •?Growth factors or immunomodulatory agents within 7 days of the administration of study treatment.
研究者
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