A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme
This is a Phase 2, multicenter, open-label, single-arm study to evaluate the antitumor
activity, safety, and pharmacology of MEDI-575 in adult subjects with first recurrence of
GBM.
Approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of
MEDI-575 in the treatment of subjects with first recurrence of GBM. Subjects will receive
MEDI-575 as a 60-minute IV infusion on Day 1 every 21 days until disease progression,
initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for
subject withdrawal.
The primary assessment of antitumor activity is PFS-6; tumor response and progression will
be determined using Updated Response Assessment Criteria of High Grade Gliomas-
Neuro-Oncology Working Group v.1. Approximately 15 investigational sites in the United
States will participate in this study. All subjects will be followed every 3 months for the
duration of the trial (defined as 9 months from the date the last subject is entered into
the trial or when the sponsor stops the study.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the progression free survival at 6 months in subjects with a recurrence of Glioblastoma Multiforme
18 months
No
Naimish Pandya, M.D.
Study Director
MedImmune LLC
United States: Food and Drug Administration
CD-ON-MEDI-575-1042
NCT01268566
January 2011
May 2013
Name | Location |
---|---|
Research Site | Mesa, Arizona |
Research Site | Anaheim, California |
Research Site | Arlington Heights, Illinois |
Research Site | Beverly, Massachusetts |
Research Site | Battle Kreek, Michigan |
Research Site | Albany, New York |
Research Site | Akron, Ohio |
Research Site | Allentown, Pennsylvania |
Research Site | Chattanooga, Tennessee |
Research Site | Abilene, Texas |
Research Site | Auburn, Washington |