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

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

Details

• Lead Sponsor: Wellstat Therapeutics
• Treatments: Antidotes; Capecitabine; Fluorouracil

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)