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NCT03419403 · ClinicalTrials.gov registry record · Phase 3
UNITE Study: Understanding New Interventions With GBM ThErapy
A Phase 3 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT03419403: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT03419403 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03419403, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafodotin (ABT-414).
Primary Outcome
Inadequate control of ocular side effects (OSE) was defined as either a ≥ 3-line decline from baseline (≥ +0.3 on LogMAR scale) in visual acuity (with baseline correction determined at the screening ophthalmology visit)) or ≥ Grade 3 OSE severity on the Corneal Epithelial Adverse Event (CEAE) scale.
Interventions
- DRUG Depatuxizumab mafodotin
- DRUG Steroid eye drops
- DRUG Vasoconstrictor eye drops
- OTHER Cold compress
- DRUG Ophthalmic steroid ointment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-07-30 |
| Est. Completion | 2020-03-03 |
| Phase | Phase 3 |
Why NCT03419403 stopped before completion
NCT03419403 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Depatuxizumab mafodotin is the first listed.
NCT03419403 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03419403 about?
NCT03419403 is a clinical study titled "UNITE Study: Understanding New Interventions With GBM ThErapy". The objective of this study was to evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects (OSEs) in participants with epidermal growth factor receptor (EGFR)-amplified glioblastoma (GBM) who were being treated with depatuxizumab mafo...
What is the current status of trial NCT03419403?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2018-07-30. Estimated completion is 2020-03-03.
What interventions are being tested in trial NCT03419403?
The interventions under investigation include: Depatuxizumab mafodotin (DRUG), Steroid eye drops (DRUG), Vasoconstrictor eye drops (DRUG), Cold compress (OTHER), Ophthalmic steroid ointment (DRUG).
Who is sponsoring clinical trial NCT03419403?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03419403's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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