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NCT01369121 · ClinicalTrials.gov registry record · Phase 1
Tolerability Study of Xerecept® in Pediatric Patients
A Phase 1 study, sponsored by Celtic Pharma Development Services.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01369121: Clinical Trial Phase 1 study, sponsored by Celtic Pharma Development Services.
NCT01369121 is a Phase 1 study that was terminated before completion, run by Celtic Pharma Development Services. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01369121, a Phase 1 study, was terminated before completion, sponsored by Celtic Pharma Development Services.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.
Primary Outcome
To define the maximum tolerated dose (MTD) of Xerecept® in pediatric patients; the MTD will be defined as the dose at which 1 or fewer of six patients experiences a dose limiting adverse event of any kind.
Interventions
- DRUG XERECEPT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
Why NCT01369121 stopped before completion
NCT01369121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which XERECEPT is the first listed.
NCT01369121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01369121 about?
NCT01369121 is a clinical study titled "Tolerability Study of Xerecept® in Pediatric Patients". This study is being conducted to evaluate the safety and tolerability of Xerecept® in children with central nervous system tumors and to identify appropriate doses of Xerecept® to be used in subsequent pediatric clinical trials.
What is the current status of trial NCT01369121?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-06. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01369121?
The interventions under investigation include: XERECEPT (DRUG).
Who is sponsoring clinical trial NCT01369121?
This trial is sponsored by Celtic Pharma Development Services, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01369121's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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