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NCT03782415 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma
A Phase 1 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT03782415: Completed Phase 1 study, sponsored by MediciNova.
NCT03782415 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03782415, a Phase 1 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in dose-finding study. Part 2 will evaluate efficacy of fixed-dose MN-166 (ibudilast) and TMZ combination treatment for 6 cycles (\~6 months) until disease progression, unacceptable tolerability and/or toxicity or loss of life.
Primary Outcome
Determine the proportion of patients with * Treatment-emergent adverse events (TEAEs) as measured by the CTCAE v4.0 and * Treatment discontinuations due to TEAEs and Dose-Limiting Toxicities (DLTs).
Interventions
- DRUG Temozolomide
- DRUG MN-166
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-12-29 |
| Est. Completion | 2023-08-07 |
| Phase | Phase 1 |
What the finished NCT03782415 record still lists
NCT03782415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Temozolomide is the first listed.
NCT03782415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03782415 about?
NCT03782415 is a clinical study titled "Study to Evaluate Ibudilast and TMZ Combo Treatment in Newly Diagnosed and Recurrent Glioblastoma". Part 1 is an open-label, single-arm, dose escalation study of MN-166 (ibudilast) and temozolomide (TMZ) combination treatment. Evaluate safety and tolerability of ibudilast (MN-166) and TMZ combination treatment for 1 cycle (28 days); determine dosage in dose-finding study. Part 2 will evaluate effi...
What is the current status of trial NCT03782415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-12-29. Estimated completion is 2023-08-07.
What interventions are being tested in trial NCT03782415?
The interventions under investigation include: Temozolomide (DRUG), MN-166 (DRUG).
Who is sponsoring clinical trial NCT03782415?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03782415's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 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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