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 2b/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 (Intellance 1)

Summary:

This study seeks to determine whether the addition of ABT-414 to concomitant radiation therapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification. In addition, this is a Phase 1, open-label, multicentre sub-study to assess the pharmacokinetics, safety and tolerability of ABT-414 in subjects with newly diagnosed EGFR-amplified GBM who have mild or moderate hepatic impairment.

Trial Description

Primary Outcome:

  • Progression Free Survival (PFS) for Phase 2b
  • Overall Survival (OS) for Phase 3
Secondary Outcome:
  • Progression Free Survival (PFS) for Phase 3
  • Overall Survival (OS) for Phase 2b
  • OS for the EGFRvIII-mutated tumour subgroup
  • PFS for EGFRvIII-mutated tumour subgroup
  • Number of days to deterioration in verbal memory (HVLT-R)
  • Number of days to deterioration in symptom severity score M.D. Anderson Symptom Inventory Brain Tumour Module (MDASI-BT)
  • Number of days to deterioration in symptom interference score (MDASI-BT)

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