Last updated on March 2018

Adult Study: ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma Pediatric Study: Evaluation of ABT-414 in Children With High Grade Gliomas


Brief description of study

This study is to evaluate the efficacy and safety of ABT-414 alone or with temozolomide versus temozolomide or lomustine alone in participants with recurrent glioblastoma multiforme.

The study includes a Pediatric sub-study to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population.

Adult enrollment has been completed and the study is now only recruiting for pediatric participants.

Detailed Study Description

The pediatric sub-study is an uncontrolled, open-label, single-arm global study. This sub-study is to evaluate the safety, tolerability, and pharmacokinetics of ABT-414 in a pediatric population less than 18 years of age as well as to assess the effect of ABT-414 on tumor response per Response Assessment in Neuro-Oncology (RANO) criteria.

Clinical Study Identifier: NCT02343406

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Lucile Packard Children's Hosp
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Swedish Medical Center
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Port Macquarie Base Hospital
Port Macquarie, Australia
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Randwick, Australia
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Royal North Shore Hospital
Saint Leonards, Australia
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Waratah, Australia
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Geelong, Australia
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