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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432301
First Posted: September 12, 2011
Last Update Posted: March 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wellstat Therapeutics
  Purpose

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.

Condition Intervention
Toxicity Due to Chemotherapy Drug: uridine triacetate

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:
    Drug: uridine triacetate
    uridine triacetate granules, 10gms, q6H x 20 doses
    Other Names:
    • PN401
    • Vistogard
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Wellstat Therapeutics
ClinicalTrials.gov Identifier: NCT01432301     History of Changes
Other Study ID Numbers: 401.10.001
First Submitted: September 8, 2011
First Posted: September 12, 2011
Last Update Posted: March 7, 2016
Last Verified: March 2016

Keywords provided by Wellstat Therapeutics:
fluorouracil overdose
fluorouracil toxicity
capecitabine overdose
capecitabine toxicity

Additional relevant MeSH terms:
Capecitabine
Fluorouracil
Antidotes
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents