Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
NCT ID: NCT00892931
Last Updated: 2011-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2009-04-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Azixa
3.3 mg/m2 of Azixa administered by intravenous infusion over 2 hours once weekly for 3 consecutive weeks every 4 weeks (1 cycle = 4 weeks)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Myrexis Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Beelen, MD
Role: STUDY_DIRECTOR
Myrexis Inc.
Lawrence Recht, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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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
Countries
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References
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Sirisoma N, Pervin A, Zhang H, Jiang S, Willardsen JA, Anderson MB, Mather G, Pleiman CM, Kasibhatla S, Tseng B, Drewe J, Cai SX. Discovery of N-(4-methoxyphenyl)-N,2-dimethylquinazolin-4-amine, a potent apoptosis inducer and efficacious anticancer agent with high blood brain barrier penetration. J Med Chem. 2009 Apr 23;52(8):2341-51. doi: 10.1021/jm801315b.
Kasibhatla S, Baichwal V, Cai SX, Roth B, Skvortsova I, Skvortsov S, Lukas P, English NM, Sirisoma N, Drewe J, Pervin A, Tseng B, Carlson RO, Pleiman CM. MPC-6827: a small-molecule inhibitor of microtubule formation that is not a substrate for multidrug resistance pumps. Cancer Res. 2007 Jun 15;67(12):5865-71. doi: 10.1158/0008-5472.CAN-07-0127.
Related Links
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Myriad Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection.
Other Identifiers
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MPC-6827-019
Identifier Type: -
Identifier Source: org_study_id