NCT01432301Approved For Marketing不适用
An Open-Label Protocol for the Use of Uridine Triacetate as an Antidote to Treat Patients at Excess Risk of 5-Fluorouracil Toxicity Due to Overdosage or Impaired Elimination
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
研究概览
简要总结
The purpose of this study is to provide emergency treatment of adult and pediatric patients:
- Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or
- Who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.
详细描述
Demographics, baseline disease information, prior disease-directed therapy including fluorouracil or capecitabine, and details of the fluorouracil or capecitabine overexposure (dose, cause, and timing) will be collected. Adverse events information will be collected and recorded. Patients will be followed for 30 days unless the patient expires or resumes chemotherapy within the 30 day period.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient received a fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or
- •The patient is exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration
- •Judged by the Investigator to have the initiative and means to be compliant with the protocol
- •Able to take oral medications
- •Able to start treatment with uridine triacetate within 96 hours after the end of fluorouracil or capecitabine administration
- •Provides written informed consent (patient or legally authorized representative)
排除标准
- •Has a known allergy to uridine triacetate or any of its excipients
- •Unable to have the initiative and means to be compliant with the protocol
- •Unable to be compliant with taking oral medications
- •More than 96 hours have elapsed since the completion of 5-FU dosing
- •Unable to provide written informed consent (patient or legally authorized representative)
研究者
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