NCT01800812已完成1 期
Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- The occurrence of any adverse event
研究概览
简要总结
Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 盲法
- None
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
- •Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed.
- •At least one month since the last chemotherapy
- •Life expectancy above 3 months
- •Written informed consent
- •Age above 18
排除标准
- •Patient's refusal
- •Infection
- •Brain metastasis
- •Autoimmune disease
- •Regular use of steroids
- •Patient included in another protocol
- •Chemotherapy or radiotherapy less than 6 weeks ago
- •Immunotherapy less than 8 weeks ago
结局指标
主要结局
The occurrence of any adverse event
时间窗: up to 8 weeks
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety DisorderGeneralized AnxietyNCT00390533Sanofi428
已完成
1 期
A Study to Assess Interaction Between JNJ-64417184 and JNJ-53718678 After Single and Multiple Dosing in Healthy ParticipantsHealthyNCT04090086Janssen Research & Development, LLC16
已完成
1 期
Phase 1 Pharmacokinetics of Intravenous Nexium in ChildrenPharmacokineticsNCT00474019AstraZeneca42
已完成
3 期
A Study of Monthly Risedronate for OsteoporosisPostmenopausal OsteoporosisNCT00247273Warner Chilcott1,294
已完成
1 期
A Study to Assess Effect of JNJ-54861911 on Pharmacokinetics of Cocktail Representatives for Cytochrome P450 (CYP) 3A4, CYP2B6, CYP2C9, and CYP1A2 SubstratesHealthyNCT02211079Janssen Research & Development, LLC16