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 Details — Status: Approved for marketing

Administrative data

• NCT number: NCT01432301
• Other study ID #: 401.10.001
• Status: Approved for marketing
• Phase: N/A
• First received: September 8, 2011
• Last updated: March 3, 2016

Study information

• Verified date: March 2016
• Source: Wellstat Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

N/A

Related Conditions & MeSH terms

• Toxicity Due to Chemotherapy

Intervention

Drug:
• uridine triacetate
uridine triacetate granules, 10gms, q6H x 20 doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wellstat Therapeutics