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Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the progression-free survival (PFS) rate

Outcome Time Frame:

Six 28-day cycles from start of therapy

Safety Issue:

No

Principal Investigator

Andrew Beelen, MD

Investigator Role:

Study Director

Investigator Affiliation:

Myrexis Inc.

Authority:

United States: Food and Drug Administration

Study ID:

MPC-6827-019

NCT ID:

NCT00892931

Start Date:

April 2009

Completion Date:

September 2011

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma
  • Brain Neoplasms
  • Recurrence
  • Glioblastoma

Name

Location

Stanford UniversityStanford, California  94305
Cedars-Sinai Medical CenterLos Angeles, California  90048
Columbia UniversityNew York, New York  10032-3784
Northwestern UniversityChicago, Illinois  60611
Barrow Neurological InstitutePhoenix, Arizona  85013
Lahey ClinicBurlington, Massachusetts  01805
Tufts Medical CenterBoston, Massachusetts  02111
University of MassachusettesWorcester, Massachusetts  01655
Darthmouth -Hitchcock Medical CenterLebanon, New Hampshire  03756
SCCA/University of WashingtonSeattle, Washington  981209