Overview

AMG 595 First-in-Human in Recurrent Gliomas

Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Amgen