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Completed

NCT Number: NCT00892931

Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azixa

Drug

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 names: MPC-6827

Primary outcomes

  1. To determine the progression-free survival (PFS) rate

    Time frame: Six 28-day cycles from start of therapy

Secondary outcomes

  1. Overall survival

    Time frame: 36 months

  2. Overall response rate

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Myrexis Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
May 5, 2009
Registry last updated
Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.