drugset / Trial / NCT01432301
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
Summary
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.
Timeline
- Start
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- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | uridine triacetate | Unknown | 10 g | — |