NCT02573324

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

A Randomized, Placebo Controlled Phase 3 Study of ABT-414 With Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance1)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 691 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	Temozolomide	Oral Capsule
DRUG	Depatuxizumab mafodotin	Intravenous (IV) Infusion
RADIATION	Radiation
DRUG	Placebo for ABT-414	IV Infusion (IV)

Timeline

• Start date: 2015-01-04
• Primary completion: 2022-04-04
• Completion: 2022-04-04
• First posted: 2015-10-09
• Last updated: 2023-05-11
• Results posted: 2023-05-11

Locations

212 sites across 28 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, France, Germany, Hong Kong, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Portugal, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study