Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

October 13, 2011 updated by: Myrexis Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Stanford, California, United States, 94305
        • Stanford University
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusettes
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Darthmouth -Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Washington
      • Seattle, Washington, United States, 981209
        • SCCA/University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the progression-free survival (PFS) rate
Time Frame: Six 28-day cycles from start of therapy
Six 28-day cycles from start of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 36 months
36 months
Overall response rate
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myrexis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

May 3, 2009

First Submitted That Met QC Criteria

May 3, 2009

First Posted (ESTIMATE)

May 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-6827-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioblastoma Multiforme

Clinical Trials on Azixa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe