2025-521674-33-00招募中2 期
A phase 2a Safety and Efficacy study of TAR-0520 gel in prevention of taxanes-induced peripheral neuropathy
Tarian Pharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
研究概览
简要总结
To confirm the local and systemic safety of TAR-0520 Gel applied twice daily to one hand and one foot, in breast cancer patients treated with taxanes.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female, who is at least 18 years of age or older at screening visit
- •Clinical diagnosis of breast cancer planned to be treated with weekly infusions of paclitaxel or docetaxel as part of the chemotherapy protocol
排除标准
- •Patient already treated with taxanes or other chemotherapies known to induce neuropathies
- •Patient with previously diagnosed peripheral neuropathy
- •Patient with concomitant therapies known to induce neuropathies
- •Patient treated for neuropathic pain
结局指标
主要结局
Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
Incidence of Adverse Events, Adverse Events of Special Interest and Serious Adverse Events
次要结局
- Incidence and severity of NCI-CTCAE (Nervous system disorders) grading by oncologist
研究者
Janusz Czernielewski
Scientific
Tarian Pharma
研究点 (1)
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