Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Myrexis Inc.

Criteria

Inclusion Criteria:

• Have histologically proven malignant Glioblastoma Multiforme in first or second relapse

• Have failed prior Fractionated External Beam Cranial Irradiation or IMRT

• Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy

• Have a Karnofsky performance status of ≥ 60

• Have adequate bone marrow function, liver function, and renal function before starting therapy

Exclusion Criteria:

• Have had more than two relapses

• Have had radiosurgery

• Have a cardiac ejection fraction < 50% by MUGA or ECHO

• Have Troponin-I elevated above the normal range

• Have an increasing steroid requirement

• Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage

• Have active stroke and/or transient ischemic attack not optimally managed

• Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension)

• Be pregnant or breast feeding

• Have had prior hypersensitivity reaction to Cremophor EL

• Be HIV positive