NCT02343406 (Clinical Trial/ ABT-414)

Study Title
ABT-414 Alone or ABT-414 Plus Temozolomide vs. Lomustine or Temozolomide for Recurrent Glioblastoma (NCT02343406)

Trial Description
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.

This trial is sponsored by AbbVie. [1]

Study Data

  • Condition: Recurrent Glioblastoma
  • Interventions:
    • Drugs used in this trial:
      • ABT-414
      • Lomustine (CeeNU®; BMS/Bristol-Myers Squibb Company)
      • Temozolomide (Temodar®; Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.)
  • Phase: II
  • Estimated Enrollment: 260
  • Start:  March 2015
  • Estimated Completion: June 2020
  • Last verified: August 2017

Study Schematic

Screen Shot 2016-07-19 at 4.46.32 PM

Trial Results
Initial results from an unrelated phase I study to evaluate the safety, pharmacokinetics, and the maximum tolerated dose (MTD) of ABT-414 when administered every 14 days with concurrent radiotherapy and temozolomide in newly diagnosed GBM patients, presented at the 2014 European Society of Medical Oncology (ESMO) Annual Congress, September 26-30, in Madrid, Spain, show that pharmacokinetics and safety data are supported a dose of 2.4 mg/kg as the predicted maximum tolerated dose. Preliminary safety data further demonstrate increased liver and eye toxicities in addition to common toxicities of radiotherapy and temozolomide. Based on these initial results, the researchers conclude that further follow-up may demonstrate whether ABT-414 improves outcome. The initial analysis of data was based on the data from 22 treated patients (13 male/9 female median age 58 years, range 34-79). [2]

Last Editorial review:  August 26, 2017
Information based on (NIH/NCI) and other sources.