Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Myrexis

Status and phase

Completed

Phase 2

Conditions

Glioblastoma Multiforme

Treatments

Drug: Azixa

Study type

Interventional

Funder types

Industry

Identifiers

MPC-6827-019

Details and patient eligibility

About

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

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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