NCT07765446招募中2 期
A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Primary Outcome
研究概览
简要总结
This Phase 2, open-label study will evaluate the safety, tolerability, and pharmacokinetics of SIR2501 in adults with solid tumors who are scheduled to receive paclitaxel-based chemotherapy. The study will also explore whether SIR2501 has the potential to reduce the development of chemotherapy-induced peripheral neuropathy (CIPN).
详细描述
SIR2501 will be administered to sequential cohorts at increasing dose levels. The study will characterize safety, pharmacokinetics, and preliminary signals related to neuropathy assessment in patients receiving paclitaxel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •Adults ≥18 years with confirmed solid tumors
- •Planned treatment with paclitaxel-based chemotherapy
- •ECOG performance status 0-2
排除标准
- •Pre-existing peripheral neuropathy
- •Conditions or medications that may interfere with neuropathy assessment
- •Prior exposure to neurotoxic chemotherapy
- •Use of medications known to mitigate CIPN
- •Significant medical conditions that may increase study risk
研究组 & 干预措施
45 mg
Experimental
干预措施: SIR2501 (Drug)
60 mg
Experimental
干预措施: SIR2501 (Drug)
30 mg
Experimental
干预措施: SIR2501 (Drug)
结局指标
主要结局
Primary Outcome
时间窗: From first dose through 1 month after last dose
Incidence of Treatment-Emergent Adverse Events
次要结局
- Secondary Outcome 1 - Pharmacokinetics: Cmax(From first dose through 1 month after last dose)
- Secondary Outcome 2 - Pharmacokinetics: AUC(From first dose through 1 month after last dose)
- Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20(From first dose through 1 month after last dose)
- Secondary Outcome 4 - Neuropathy: TNS/TNSc(From first dose through 1 month after last dose)
- Secondary Outcome 6 - Neuropathy:(From first dose through 1 month after last dose)
- Secondary Outcome 7 - Pharmacodynamics: NfL(From first dose through 1 month after last dose)
研究者
研究点 (4)
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