drugset / Trial / NCT01432301

Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination

NCT01432301 ↗

Expanded access Approved for marketing Wellstat Therapeutics

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

EvaluationDrugModalityDoseRoute
Subject uridine triacetate Unknown 10 g —