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

NCT ID: NCT01432301

Last Updated: 2016-03-07

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

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 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.

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.

Conditions

Toxicity Due to Chemotherapy

Interventions

uridine triacetate

uridine triacetate granules, 10gms, q6H x 20 doses

Intervention Type: DRUG

Other Intervention Names

PN401; Vistogard

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wellstat Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

401.10.001

Identifier Type: -

Identifier Source: org_study_id