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

NCT01432301 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2016-03-07

No results posted yet for this study

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

Interventions

DRUG

uridine triacetate

uridine triacetate granules, 10gms, q6H x 20 doses

Sponsors & Collaborators

  • Wellstat Therapeutics

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01432301 on ClinicalTrials.gov