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

Official Title

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)

Summary:

This study seeks to determine whether the addition of ABT-414 to concomitant radiation therapy 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, multicentre 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.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • OS for the O6-methylguaninemethlytransferese (MGMT) methylated subgroup
  • Number of days to deterioration in symptom severity score M.D. Anderson Symptom Inventory Brain Tumour Module (MDASI-BT)
  • OS for the EGFRvIII-mutated tumour subgroup
  • Number of days to deterioration in neurocognitive functioning on the Hopkins Verbal Learning Test Revised (HVLT-R)
  • Progression Free Survival (PFS)
  • Number of days to deterioration in symptom interference score (MDASI-BT)
  • PFS for EGFRvIII-mutated tumour subgroup

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society