NCT02442466终止早期 1 期
Proof of Concept Study With an Endothelin Receptor B Inhibitor (BQ-788) for Human Melanoma
MelCure SA0 个研究点目标入组 5 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 主要终点
- Tumour response by size measurement and histological examination
研究概览
简要总结
Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788) or vehicle was preformed in 5 melanoma patients to have a preliminary analysis of safety, dose, duration and relevance of results observed in pre-clinical studies to the human disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed consent
- •Histologically confirmed melanoma
- •Disease stage III or IV
- •At least 2 injectable and surgically removable cutaneous metastasis
- •Age > 18 years
- •Clinically stable medical condition
排除标准
- •Primary ocular melanoma
- •Symptomatic intracranial melanoma
- •History of severe neurological, cardiovascular, renal, hepatic, endocrinological, respiratory, bone marrow, autoimmune or infectious (HIV) disease
- •Pregnancy or lactation
研究组 & 干预措施
Endothelin receptor B inhibitor BQ-788
Experimental
Intra-lesion administration of an Endothelin Receptor B inhibitor (BQ-788)
干预措施: Endothelin Receptor B inhibitor BQ788 (Drug)
PBS
Experimental
Intra-lesion administration of vehicle
干预措施: PBS (Drug)
结局指标
主要结局
Tumour response by size measurement and histological examination
时间窗: 3 to14 days
次要结局
- Evaluation of changes in mRNA as well as protein expression levels of Endothelin Receptor B by PCR and Ab staining(3 to 14 days)
- Evaluation of changes in blood vessels formation by histological examination using Ab staining(3 to 14 days)
- Measuring changes in tumor cell proliferation by histological analyses using Ab staining(3 to 14 days)
- Evaluation of changes in immune cell infiltration by histological examination using Ab staining(3 to 14 days)
研究者
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