A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-414 in Combination With Radiation Plus Temozolomide or Temozolomide Alone for Subjects With Glioblastoma Multiforme
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (Number of subjects with adverse events and/or dose limiting toxicities)
Evaluation of clinical lab testing, adverse event monitoring, and evaluation of vital signs, physical exam, and electrocardiogram (ECG) (periodic)
Every week for an expected average of 34 weeks
Yes
Kyle Holen, MD
Study Director
AbbVie
Australia: Department of Health and Ageing Therapeutic Goods Administration
M12-356
NCT01800695
April 2013
September 2015
Name | Location |
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Site Reference ID/Investigator# 90773 | San Antonio, Texas 78258 |