Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Phase 2

Completed

• Conditions: Glioblastoma Multiforme

• Registration Number: NCT00892931
• Lead Sponsor: Myrexis Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-03
• Study First Submitted QC: 2009-05-03
• Study First Posted: 2009-05-05
• Primary Completion: 2011-07
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-13
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the progression-free survival (PFS) rate	Six 28-day cycles from start of therapy

Secondary Outcome Measures

Name	Time	Method
Overall survival	36 months
Overall response rate	18 months

Trial Locations

Locations (10)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Massachusettes; 🇺🇸 Worcester, Massachusetts, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

SCCA/University of Washington; 🇺🇸 Seattle, Washington, United States

Columbia University; 🇺🇸 New York, New York, United States

Darthmouth -Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States