Status:
COMPLETED
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
Lead Sponsor:
Myrexis Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00892931
Start Date
April 1 2009
End Date
September 1 2011
Last Update
October 14 2011
Active Locations (10)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Stanford University
Stanford, California, United States, 94305
4
Northwestern University
Chicago, Illinois, United States, 60611