Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
This treatment has been approved for sale to the public.
First Posted: September 12, 2011
Last Update Posted: March 7, 2016
Information provided by (Responsible Party):
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.
|Study Type:||Expanded Access What is Expanded Access?|
|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|
Resource links provided by NLM:
Further study details as provided by Wellstat Therapeutics:
Intervention Details:Detailed Description:
Drug: uridine triacetate
uridine triacetate granules, 10gms, q6H x 20 doses
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.
Contacts and Locations
No Contacts or Locations Provided