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

Toxicity Due to Chemotherapy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01432301
Study type Expanded Access
Source Wellstat Therapeutics
Contact
Status Approved for marketing
Phase N/A
View Details
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