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Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00892931
Recruitment Status : Completed
First Posted : May 5, 2009
Last Update Posted : October 14, 2011
Information provided by (Responsible Party):
Myrexis Inc.

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

Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Azixa Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
Study Start Date : April 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: 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 Name: MPC-6827

Primary Outcome Measures :
  1. To determine the progression-free survival (PFS) rate [ Time Frame: Six 28-day cycles from start of therapy ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]
  2. Overall response rate [ Time Frame: 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00892931

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United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Stanford University
Stanford, California, United States, 94305
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Lahey Clinic
Burlington, Massachusetts, United States, 01805
University of Massachusettes
Worcester, Massachusetts, United States, 01655
United States, New Hampshire
Darthmouth -Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Washington
SCCA/University of Washington
Seattle, Washington, United States, 981209
Sponsors and Collaborators
Myrexis Inc.
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Study Director: Andrew Beelen, MD Myrexis Inc.
Principal Investigator: Lawrence Recht, MD Stanford University
Additional Information:
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Responsible Party: Myrexis Inc. Identifier: NCT00892931    
Other Study ID Numbers: MPC-6827-019
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011
Keywords provided by Myrexis Inc.:
Brain Neoplasms
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue