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NCT03206021 · ClinicalTrials.gov registry record · Phase 1
COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors
A Phase 1 study, sponsored by The Hospital for Sick Children.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT03206021: Completed Phase 1 study, sponsored by The Hospital for Sick Children.
NCT03206021 is a Phase 1 study that has completed, run by The Hospital for Sick Children. The registered enrollment target is 31 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03206021, a Phase 1 study, has completed, sponsored by The Hospital for Sick Children.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
Many pediatric brain and solid tumors have altered epigenetic landscapes, and altered DNA methylation. As such this study is a Phase I/Ib study of combined 5'Azacitidine with an escalating dose of carboplatin for all recurrent/refractory pediatric brain and solid tumors. The phase I component will establish with maximum tolerated dose of carboplatin with azacytidine. An expansion cohort will be recruited of up to 30 patients will follow consisting of 20 recurrent posterior fossa ependymoma and 10 recurrent supratentorial ependymoma.
Primary Outcome
Number of participants with treatment-related adverse events as assessed by the CTCAE4.0
Interventions
- DRUG 5 Azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2024-03-01 |
| Phase | Phase 1 |
What the finished NCT03206021 record still lists
NCT03206021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 1 intervention - of which 5 Azacytidine is the first listed.
NCT03206021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03206021 about?
NCT03206021 is a clinical study titled "COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors". Many pediatric brain and solid tumors have altered epigenetic landscapes, and altered DNA methylation. As such this study is a Phase I/Ib study of combined 5'Azacitidine with an escalating dose of carboplatin for all recurrent/refractory pediatric brain and solid tumors. The phase I component will e...
What is the current status of trial NCT03206021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2017-08-01. Estimated completion is 2024-03-01.
What interventions are being tested in trial NCT03206021?
The interventions under investigation include: 5 Azacytidine (DRUG).
Who is sponsoring clinical trial NCT03206021?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03206021's enrollment target sits among peer trials
31 1322nd of 2000 higher than 669 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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