Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
This study has been completed.
Sponsor:
Myrexis Inc.
Information provided by (Responsible Party):
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00892931
First received: May 3, 2009
Last updated: October 13, 2011
Last verified: October 2011
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Purpose
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme |
Drug: Azixa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by Myrexis Inc.:
Primary Outcome Measures:
- To determine the progression-free survival (PFS) rate [ Time Frame: Six 28-day cycles from start of therapy ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 56 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Azixa
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 Name: MPC-6827
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892931
Locations
| United States, Arizona | |
| Barrow Neurological Institute | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Tufts Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| University of Massachusettes | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New Hampshire | |
| Darthmouth -Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| United States, Washington | |
| SCCA/University of Washington | |
| Seattle, Washington, United States, 981209 | |
Sponsors and Collaborators
Myrexis Inc.
Investigators
| Study Director: | Andrew Beelen, MD | Myrexis Inc. |
| Principal Investigator: | Lawrence Recht, MD | Stanford University |
More Information
Additional Information:
Publications:
| Responsible Party: | Myrexis Inc. |
| ClinicalTrials.gov Identifier: | NCT00892931 History of Changes |
| Other Study ID Numbers: | MPC-6827-019 |
| Study First Received: | May 3, 2009 |
| Last Updated: | October 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Myrexis Inc.:
|
Glioblastoma Brain Neoplasms Recurrence |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 16, 2013