NCT02573324 (Clinical Trial/ ABT-414)

Study Title

A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1) (NCT02573324)

Trial Description

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in 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 subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

This trial is sponsored by AbbVie.®

Study Data

  • Condition:
    •  Glioblastoma
    • Gliosarcoma
  • Interventions:
    • Drugs used in this trial
      • ABT-414
      • Temozolomide
      • Radiation
  • Phase: II
  • Enrollment: 720
  • Start: December 2017
  • Estimated Completion: April 2020
  • Last verified: May 2017
  • Last Updated: May 2017

Study Schematic

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Last Editorial review: August 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.