Toxicity Due to ChemotherapyNCT01432301
Uridine Triacetate as Antidote for Patients at Excess Risk of 5-FU Toxicity Due to Overdosage or Impaired Elimination
A study testing uridine triacetate in people with Toxicity Due to Chemotherapy, run by Wellstat Therapeutics.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toxicity Due to Chemotherapy
- What is being tested?
- uridine triacetate
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
About this study
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
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.
Read the 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
- Being tested
- uridine triacetate
- Keywords
- fluorouracil overdose, fluorouracil toxicity, capecitabine overdose, capecitabine toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uridine triacetateDrug
Also called PN401, Vistogard
uridine triacetate granules, 10gms, q6H x 20 doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity Due to ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Wellstat Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432301
- Sponsor's protocol ID
- 401.10.001
- Status last verified
- Mar 2016
- First submitted
- 8 Sep 2011
- Last updated
- 7 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01432301
- Acronym / sponsor ID
- 401.10.001
- Conditions
- Toxicity Due to Chemotherapy
- Keywords
- fluorouracil overdose, fluorouracil toxicity, capecitabine overdose, capecitabine toxicity
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Wellstat TherapeuticsIndustry (pharma, biotech, devices)
- First posted
- 12 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| uridine triacetateAlso: PN401, Vistogarduridine triacetate granules, 10gms, q6H x 20 doses | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
Related trials for Toxicity Due to Chemotherapy
Recruiting
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments
Sarcopenia, Oncology
RecruitingObservational study
Impact of Gonadotoxic Therapies on Fertility
Cancer, Fertility Issues
Active, not recruitingObservational study
Investigating Cardiovascular Adverse Events Related to Cancer Treatment
Toxicity Due to Chemotherapy, Cardiovascular Morbidity
Not yet recruitingPhase 1/2
Dose Optimization and Efficacy Assessment of a Fluoropyrimidine Antidote
Cancer, Toxicity Due to Chemotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing uridine triacetate in people with Toxicity Due to Chemotherapy, run by Wellstat Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.