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NCT02573324 · ClinicalTrials.gov registry record · Phase 3
A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 691
- Enrollment target
NCT02573324: Completed Phase 3 study, sponsored by AbbVie.
NCT02573324 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 691 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02573324, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 691 participants
- Enrollment target
Study Summary
This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, there is a Phase 1, open-label, multicenter sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in participants with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.
Primary Outcome
Time to OS is defined as the number of days from the date of randomization to the date of death due to any cause.
Interventions
- DRUG Temozolomide
- RADIATION Radiation
- DRUG Depatuxizumab mafodotin
- DRUG Placebo for ABT-414
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 691 participants |
| Start Date | 2015-01-04 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 3 |
What the finished NCT02573324 record still lists
NCT02573324 is an interventional study that assigns participants to a tested intervention. The registered 691 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT02573324 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02573324 about?
NCT02573324 is a clinical study titled "A Study of ABT-414 in Participants With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification". This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) followed by combination of ABT-414 with adjuvant TMZ prolongs overall survival (OS) among participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR)...
What is the current status of trial NCT02573324?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 691 participants. The study started on 2015-01-04. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT02573324?
The interventions under investigation include: Temozolomide (DRUG), Radiation (RADIATION), Depatuxizumab mafodotin (DRUG), Placebo for ABT-414 (DRUG).
Who is sponsoring clinical trial NCT02573324?
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 NCT02573324's enrollment target sits among peer trials
691 524th of 2000 higher than 1,477 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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