A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Advers events
研究概览
简要总结
Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities.
The aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine.
Is the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake.
Feet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks.
Clinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.
详细描述
Hand-foot syndrome (HFS) is a well-established cutaneous adverse event of certain chemotherapeutic agents mainly capecitabine. HFS is characterized by a wide variety of symptoms ranging from mild discomfort to a painful sensation of palms and soles that could limit functionality and hamper patients on their daily activities. Although not life threatening, it may have a severe impact on quality of life, including incapacity in working or walking, leading possibly to cancer drug discontinuation or dose modification .
The current study aims at exploring the TAR-0520 gel safety and preventative efficacy of HFS in patients with colorectal and breast cancer treated with capecitabine.
This will be an open-label, intra-individual, monocentric, pilot study with approximately 25 patients included.
Patients with histologically confirmed breast cancer or colorectal cancer receiving capecitabine monotherapy with recommended dose (≥ 1000 mg/m² twice daily from day 1 to 14 every 3 weeks) will be enrolled in the trial.
Each patient will receive the active TAR-0520 gel containing 1.5% of Brimonidine tartrate. They will be instructed to apply it to both hands, twice daily. TAR-0520 gel applications will take place approximately one hour before each morning and evening capecitabine oral intake. Feet will be non-treated and will serve as controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine
- •at a dose > 1000mg/m² twice daily every 2 out of 3 weeks as single agent chemotherapy
- •Patients with life expectancy graeter than 12 weeks
排除标准
- •Patient with medical history of capecitabine treatment
- •patient with pre-existing neuropathy confounding assessement of HFS
- •Patient with Raynaud's syndrome or other vascular peripheral disorders
- •Patient with dermatological lesions on hands or foot
研究组 & 干预措施
TAR-0520 gel
Treatment of the hands
干预措施: TAR-0520 gel (Drug)
结局指标
主要结局
Advers events
时间窗: Baseline, Day 1 of each Cycle ( Cycle1,2,3,4 and 5), each Cycle duration is 21 days
次要结局
- Severity of HFS on hands and foot(Baseline, Day 1 of each Cycle (Cycle 1,2,3,4 and 5) each Cycle duration is 21 days)