Overview

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

Status:
Active, not recruiting

Trial end date:
2021-12-31

Target enrollment:

Participant gender:

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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

AbbVie

Collaborator:

Radiation Therapy Oncology Group

Treatments:

Dacarbazine
Immunoconjugates
Mitogens
Temozolomide