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NCT03572530 · ClinicalTrials.gov registry record · Phase 1
Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma
A Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03572530: Completed Phase 1 study, sponsored by The University of Texas Health Science Center, Houston.
NCT03572530 is a Phase 1 study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572530, a Phase 1 study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions into the fourth ventricle of the brain. The study's primary objective is to establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients with recurrent ependymoma. The study's secondary objective is to assess the antitumor activity of 5-Azacytidine infusions into the fourth ventricle based upon imaging studies and cytology.
Primary Outcome
Dose-limiting toxicity will be defined as any of the following events: New neurological deficit (grade 3 or higher) probably or definitely attributed to intraventricular 5-azacytidine infusions. New adverse event involving any organ probably or definitely attributed to intraventricular 5-azacytidine infusions with the specific exclusion of: Grade 3 or higher nausea and vomiting \< 3 days duration and grade 3 or higher headache \< 3 days duration.
Interventions
- DRUG 5-Azacytidine (5-AZA) group 1
- DRUG 5-Azacytidine (5-AZA) group 2
- DRUG 5-Azacytidine (5-AZA) group 3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2020-11-24 |
| Phase | Phase 1 |
What the finished NCT03572530 record still lists
NCT03572530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which 5-Azacytidine (5-AZA) group 1 is the first listed.
NCT03572530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03572530 about?
NCT03572530 is a clinical study titled "Infusion of 5-Azacytidine (5-AZA) Into the Fourth Ventricle in Patients With Recurrent Posterior Fossa Ependymoma". This study seeks to determine the optimum dose frequency of 5-Azacytidin (5-AZA) infusions into the fourth ventricle of the brain. The study's primary objective is to establish the maximum tolerated dose for infusions of 5-Azacytidine into the fourth ventricle in patients with recurrent ependymoma. ...
What is the current status of trial NCT03572530?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-02-08. Estimated completion is 2020-11-24.
What interventions are being tested in trial NCT03572530?
The interventions under investigation include: 5-Azacytidine (5-AZA) group 1 (DRUG), 5-Azacytidine (5-AZA) group 2 (DRUG), 5-Azacytidine (5-AZA) group 3 (DRUG).
Who is sponsoring clinical trial NCT03572530?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03572530's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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