2025-524008-32-00招募中2 期
A phase 2a exploratory study of TAR-0520 gel in prevention of Hand and Foot Syndrome
Tarian Pharma1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年2月16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
- 25
- 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
Safety of TAR-0520 Gel in colorectal or breast cancer patients treated with capecitabine.
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
- •Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine monotherapy, either in adjuvant/neoadjuvant or palliative setting
- •Starting capecitabine at a dose ≥ 1000 mg/ m² twice daily every 2 out of 3 weeks as single-agent chemotherapy
排除标准
- •Patient with a medical history of capecitabine treatment
- •Patient with pre-existing grade 2 or higher neuropathy confounding assessment of HFS
- •Patient with Raynaud’s syndrome or other vascular peripheral disorders
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 (Palmar-plantar erythrodysesthesia syndrome) grading by oncologist
研究者
Janusz Czernielewski
Scientific
Tarian Pharma
研究点 (1)
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