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NCT03119064 · ClinicalTrials.gov registry record · Phase 1
BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma
A Phase 1 study, sponsored by Brown University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03119064: Clinical Trial Phase 1 study, sponsored by Brown University.
NCT03119064 is a Phase 1 study that was terminated before completion, run by Brown University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03119064, a Phase 1 study, was terminated before completion, sponsored by Brown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to cross the blood brain barrier is improved. This phase I study will establish the MTD of the combination of nanoliposomal irinotecan in combination with temozolomide safety and preliminary clinical efficacy of the combination of nanoliposomal irinotecan and metronomic temozolomide.
Primary Outcome
To evaluate the maximum tolerated dose of nanoliposomal irinotecan with continuous low-dose temozolomide for patients with recurrent glioblastoma.
Interventions
- DRUG Temozolomide
- DRUG Nanoliposomal Irinotecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2021-10-08 |
| Phase | Phase 1 |
Why NCT03119064 stopped before completion
NCT03119064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT03119064 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03119064 about?
NCT03119064 is a clinical study titled "BrUOG 329 Onivyde & Metronomic Temozolomide in Recurrent Glioblastoma". New treatments are greatly needed for patients with recurrent glioblastoma. Metronomic temozolomide is a standard treatment option but has, at best, modest activity. The nanoliposomal irinotecan may be much more active than the parent compound irinotecan since nanoliposomal irinotecan's ability to c...
What is the current status of trial NCT03119064?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-11-30. Estimated completion is 2021-10-08.
What interventions are being tested in trial NCT03119064?
The interventions under investigation include: Temozolomide (DRUG), Nanoliposomal Irinotecan (DRUG).
Who is sponsoring clinical trial NCT03119064?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03119064's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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