NCT01475006 (Clinical Trial/ AMG 595)

Study Title
AMG 595 First-in-Human in Recurrent Gliomas (NCT01475006)

Trial Description
This is an open-label, sequential dose exploration study of single agent AMG 595 administered in subjects with recurrent glioblastoma multiforme (GBM) and/or anaplastic astrocytomas (AA). The purpose of the study is to evaluate safety, tolerability, and pharmacokinetics (PK) of AMG 595, and also to evaluate the objective response rate in subjects receiving AMG 595.

This study will be conducted in two parts. Part 1 will explore doses of AMG 595 in subjects with recurrent GBM and/or AA. Part 2 (dose expansion) will examine the MTD established in Part 1 in subjects with recurrent GBM. This trial is sponsored by Amgen. [1]

Study Data

  • Condition: Recurrent Gliomas
  • Interventions:
    • Drugs used in this trial
      • AMG 595
  • Phase: I
  • Enrollment: 32
  • Start: February 2012
  • Estimated Completion: April 2016
  • Last Verified: April 2016

Study Schematic

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Last Editorial review: August 28, 2017
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.