NL-OMON30987尚未招募2 期
Identification of biological effects of bevacizumab in surgically resectable melanoma tumors. - Identification of biological effect of bevacizumab in melanoma patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Surgically resectable melanoma.
- •WHO performance status 0-2.
- •Age >18 years.
- •Minimum required laboratory data:
- •Hematology: Leucocytes 4,0-10,0x109/l.
- •Biochemistry: bilirubin < 1.5 x upper normal limit. Serum creatinine within normal limits INR < 1.5.
- •Before patient registration/randomization, written informed consent must be given according to national and local regulations.
- •Able to comply with the protocol
排除标准
- •Prior chemotherapy or biological therapy for metastatic disease.
- •Prior radiotherapy on the involved area.
- •Major surgery within 28 days before the initiation of the study.
- •Clinically significant cardiovascular disease.
- •Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
- •CNS metastases (CT-Scan not mandatory).
- •Treatment with any investigational drug within 30 days before the start of the study.
- •Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
研究者
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