NCT01563302已完成1 期
A Phase 1/2 Study of ISIS 481464, an Antisense Oligonucleotide Inhibitor of STAT3, Administered to Patients With Advanced Cancers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 9
- 主要终点
- Safety of IONIS-STAT3Rx in patients with Advanced Cancers
研究概览
简要总结
This is a Phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. Eligible patients with DLBCL or other advanced lymphomas will be enrolled into the dose-expansion cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Aged 18 years or older
- •Tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists
- •Expansion cohort only: Advanced lymphoma confirmed by histopathology
- •Measurable or evaluable disease according to RECIST for solid tumors or according to IWRC for NHL tumors
- •ECOG Performance Status less than or equal to 2
- •Life expectancy greater than 12 weeks in the opinion of the Investigator
排除标准
- •Any active or uncontrolled infection
- •NYHA Grade II or greater congestive heart failure
- •History of myocardial infarction within 6 months prior to screening
- •Prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter
研究组 & 干预措施
Group 1
Experimental
IONIS-STAT3Rx
干预措施: IONIS-STAT3Rx (Drug)
结局指标
主要结局
Safety of IONIS-STAT3Rx in patients with Advanced Cancers
时间窗: Approximately 28 days after last dose of IONIS -STAT3Rx
Maximum-tolerated dose (MTD) of IONIS-STAT3Rx in patients with Advanced Cancers.
时间窗: Approximately 28 Days
Highest dose level at which no more than 1 out of 6 patients develops a DLT
次要结局
- Clinical activity of IONIS-STAT3Rx(Approximately 28 Days after last dose of IONIS-STAT3Rx)
- STAT3 and other biomarkers(Approximately 28 days after last dose of IONIS-STAT3Rx)
- Pharmacokinetics-Cmax(Approximately 28 days after last dose of IONIS-STAT3Rx)
- Pharmacokinetics - Tmax(Approximately 28 days after last dose of IONIS-STAT3Rx)
研究者
研究点 (9)
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