Status:
APPROVED_FOR_MARKETING
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
Lead Sponsor:
Wellstat Therapeutics
Conditions:
Toxicity Due to Chemotherapy
Eligibility:
All Genders
Brief 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 exhibi...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01432301
Last Update
March 7 2016
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