EUCTR2009-016487-36-IT进行中（未招募）不适用
Phase II multicenter study with Fotemustine and Temozolomide modulation in patients with metastatic melanoma (MM) - Phase II multicenter study with Fotemustine and Temozolomide in MM
GOIM GRUPPO ONCOLOGICO MERIDIONALE0 个研究点开始时间: 2010年3月3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
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 confirmed, unresectable, stage IV metastatic melanoma; ?Measurable disease (based on RECIST criteria) including patients with brain stabilized metastases; ?No prior treatments for metastatc disease ?Patients of at list 18 years of age; ?Performance status of 0-2 (ECOG); ?Adequate hepatic and bone function (Hb >10 g/dL, ANC >2000/uL, PLT >100.000/uL; AST and ALT <1.5 x UNL, alcaline phosphatase, <5 x UNL; creatinina <1.25 x UNL); ?Life expectancy of at least 12 weeks; ?Writen informed consent
- •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
- •?History of prior malignancies within the past 5 years other than carcinoma in situ of the cervix and non-melanomatous skin cancers; ?History of myocardial infarction within 12 months prior to randomization; ?History of psychological disorders might not permit the patient to complete the study or sign the informed consent; ?Active infections; ?Use od concomitant experimental drugs.
研究者
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