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

NCT01432301 | Unknown

• 1 other identifier: 401.10.001
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Toxicity Due to Chemotherapy

Keywords

fluorouracil overdose; fluorouracil toxicity; capecitabine overdose; capecitabine toxicity

Interventions

uridine triacetate DRUG

uridine triacetate granules, 10gms, q6H x 20 doses

Also known as: PN401, Vistogard

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wellstat Therapeutics: lead

MeSH Terms

Interventions

uridine triacetate

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 12, 2011
• Last Updated: March 7, 2016

Record last verified: 2016-03