Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme

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

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