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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 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 691 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02573324
The ClinicalTrials.gov registry entry for NCT02573324 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 691 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Temozolomide is the first listed.
NCT02573324 reports 0 study locations.
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.
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