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

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Sponsor:
Information provided by (Responsible Party):
Wellstat Therapeutics
ClinicalTrials.gov Identifier:
NCT01432301
First received: September 8, 2011
Last updated: March 3, 2016
Last verified: March 2016
  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

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 
Study First Received: September 8, 2011
Last Updated: March 3, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 22, 2016