Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00892931
First received: May 3, 2009
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

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


Condition Intervention Phase
Glioblastoma Multiforme
Drug: Azixa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • To determine the progression-free survival (PFS) rate [ Time Frame: Six 28-day cycles from start of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892931

Locations
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.
Investigators
Study Director: Andrew Beelen, MD Myrexis Inc.
Principal Investigator: Lawrence Recht, MD Stanford University
  More Information

Additional Information:
Publications:
Responsible Party: Myrexis Inc.
ClinicalTrials.gov Identifier: NCT00892931     History of Changes
Other Study ID Numbers: MPC-6827-019
Study First Received: May 3, 2009
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Glioblastoma
Brain Neoplasms
Recurrence

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on August 21, 2014