NCT01432301

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

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

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Wellstat Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Toxicity Due to Chemotherapy

Interventions

Type	Name	Description
DRUG	uridine triacetate	uridine triacetate granules, 10gms, q6H x 20 doses

Timeline

• First posted: 2011-09-12
• Last updated: 2016-03-07