NCT01268566

A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme

A Phase 2 Study of MEDI-575 in Adult Subjects With Recurrent Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma Multiforme

Interventions

Type	Name	Description
DRUG	MEDI-575	MEDI-575 as an IV infusion.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2010-12-31
• Last updated: 2017-04-06
• Results posted: 2017-04-06

Locations

12 sites across 1 country: United States