ACTRN12613000302752撤回1 期
A phase I/Ib study to determine the safety and tolerability of Dz13 DNAzyme targeting c-Jun, administered to subjects with in-transit or satellite melanoma metastases via single intra tumoural injections of 100 mcg twice weekly
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Diagnosed dermal in-transit or satellite metastatic melanoma with at least 3 measurable lesions at minimum distance of 5 cm from each other
- •ECOG performance status 0-1
- •Acceptable haematologic, coagulation, renal and hepatic function
排除标准
- •Metastatic/in-transit or satellite lesions located on face, head and neck
- •Women of child bearing age
- •Prior or co-existing malignancy
- •Radiotherapy to >30% bone marrow in previous 3 months
- •Clinically significant non-malignant disease
- •Current immunosuppression
- •History of immune-mediated throbocytopenia or other platelet disease
- •Enrolment in another clinical study involving any other investigational agent
研究者
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