Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 62
Healthy volunteers: no

Brief summary:
The primary objective of this Phase II study is to evaluate the progression-free survival at 6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated with MEDI-575.

Detailed description:
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.

Arms:
arm 1: MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minutes on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participants withdrawal.

Interventions: intervention 1: MEDI-575
Intervention descriptions: intervention 1: MEDI-575 as an IV infusion.

Protocol document: