CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 691 enrolled
Drug / intervention
Temozolomide +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02573324
NCT02573324Phase 3Completed
CompareCT.gov

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)

AbbVie·interventional·Posted Oct 9, 2015·Updated May 11, 2023

In Brief

A Phase 3 clinical trial evaluating Temozolomide, Depatuxizumab mafodotin, and 2 other interventions for Glioblastoma and Gliosarcoma. Completed, enrolled 691 participants across 212 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlioblastoma, Gliosarcoma
CountriesArgentina, 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, United States
CollaboratorsRadiation Therapy Oncology Group

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 9, 2015
Enrollment StartJan 4, 2015
Primary CompletionApr 4, 2022
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 10.7 years ago

Interventions

Temozolomidedrug

Oral Capsule

Depatuxizumab mafodotindrug

Intravenous (IV) Infusion

Radiationradiation

Placebo for ABT-414drug

IV Infusion (IV)