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NCT01498783 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma
A Phase 1 study, sponsored by St. Jude Children's Research Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01498783: Completed Phase 1 study, sponsored by St. Jude Children's Research Hospital.
NCT01498783 is a Phase 1 study that has completed, run by St. Jude Children's Research Hospital. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498783, a Phase 1 study, has completed, sponsored by St. Jude Children's Research Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a phase I study to investigate the safety and pharmacokinetics of weekly 5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with recurrent or refractory ependymoma. The results from this study will inform a subsequent phase II St. Jude investigator-initiated trial.
Primary Outcome
To investigate the safety and pharmacokinetics (plasma and cerebrospinal fluid) of weekly bolus dose 5-fluorouracil (5-FU) in children and young adults with recurrent/refractory ependymoma
Interventions
- DRUG 5-fluorouracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
What the finished NCT01498783 record still lists
NCT01498783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which 5-fluorouracil is the first listed.
NCT01498783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01498783 about?
NCT01498783 is a clinical study titled "Phase I Study of 5-Fluorouracil in Children and Young Adults With Recurrent Ependymoma". This is a phase I study to investigate the safety and pharmacokinetics of weekly 5-fluorouracil (5-FU) administered as a bolus dose in children and young adults with recurrent or refractory ependymoma. The results from this study will inform a subsequent phase II St. Jude investigator-initiated tria...
What is the current status of trial NCT01498783?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2011-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01498783?
The interventions under investigation include: 5-fluorouracil (DRUG).
Who is sponsoring clinical trial NCT01498783?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01498783's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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