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Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00892931
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Myrexis Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Andrew Beelen, MDLawrence Recht, MD
Principal Investigator Affiliation Myrexis Inc.Stanford University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Barrow Neurological Institute, Phoenix, Arizona

Status

Address

Barrow Neurological Institute

Phoenix, Arizona, 85013

Cedars-Sinai Medical Center, Los Angeles, California

Status

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Stanford University, Stanford, California

Status

Address

Stanford University

Stanford, California, 94305

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Tufts Medical Center, Boston, Massachusetts

Status

Address

Tufts Medical Center

Boston, Massachusetts, 02111

Lahey Clinic, Burlington, Massachusetts

Status

Address

Lahey Clinic

Burlington, Massachusetts, 01805

University of Massachusettes, Worcester, Massachusetts

Status

Address

University of Massachusettes

Worcester, Massachusetts, 01655

Darthmouth -Hitchcock Medical Center, Lebanon, New Hampshire

Status

Address

Darthmouth -Hitchcock Medical Center

Lebanon, New Hampshire, 03756

Columbia University, New York, New York

Status

Address

Columbia University

New York, New York, 10032

SCCA/University of Washington, Seattle, Washington

Status

Address

SCCA/University of Washington

Seattle, Washington, 981209

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