Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
Completed · Phase 2
Conditions studied: Glioblastoma Multiforme
In brief
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Key facts
- Study ID
- NCT00892931
- Run by
- Myrexis Inc.
- People needed
- 56
- Starts
- 2009-04-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2011-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Barrow Neurological Institute — Phoenix, Arizona, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Stanford University — Stanford, California, United States
- Northwestern University — Chicago, Illinois, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- University of Massachusettes — Worcester, Massachusetts, United States
- Darthmouth -Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Columbia University — New York, New York, United States
- SCCA/University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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