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NCT02774421 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma
A Phase 1 study of Posterior Fossa Ependymoma (PFEPN), sponsored by University of Colorado, Denver.
- Active
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT02774421: Active Phase 1 study of Posterior Fossa Ependymoma (PFEPN), sponsored by University of Colorado, Denver.
NCT02774421 is a Phase 1 study of Posterior Fossa Ependymoma (PFEPN) that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02774421, a Phase 1 study of Posterior Fossa Ependymoma (PFEPN), is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor (GM-CSF) in children with relapsed PFEPN
Primary Outcome
The presence of trastuzumab will be measured as a binary (yes/no) outcome.
Conditions Studied
Interventions
- DRUG Trastuzumab after SubQ GM-CSF
- DRUG Trastuzumab in combination with SubQ GM-CSF
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What the registry record for NCT02774421 still lists
NCT02774421 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Posterior Fossa Ependymoma (PFEPN) appearing as the primary indexed condition, and to 2 interventions - of which Trastuzumab after SubQ GM-CSF is the first listed.
NCT02774421 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT02774421 about?
NCT02774421 is a clinical study titled "Pilot Study of the Effect of Trastuzumab and GM-CSF on Children With Recurrent Ependymoma". This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ)...
What is the current status of trial NCT02774421?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2017-06-12. Estimated completion is 2026-03.
What conditions does trial NCT02774421 study?
This clinical trial studies the following conditions: Posterior Fossa Ependymoma (PFEPN).
What interventions are being tested in trial NCT02774421?
The interventions under investigation include: Trastuzumab after SubQ GM-CSF (DRUG), Trastuzumab in combination with SubQ GM-CSF (DRUG).
Who is sponsoring clinical trial NCT02774421?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02774421 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02774421's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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