Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

NCT ID: NCT00892931

Last Updated: 2011-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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MPC-6827

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myrexis Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Beelen, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Lawrence Recht, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Stanford University

Stanford, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Lahey Clinic

Burlington, Massachusetts, United States

Site Status

University of Massachusettes

Worcester, Massachusetts, United States

Site Status

Darthmouth -Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Columbia University

New York, New York, United States

Site Status

SCCA/University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Sirisoma N, Pervin A, Zhang H, Jiang S, Willardsen JA, Anderson MB, Mather G, Pleiman CM, Kasibhatla S, Tseng B, Drewe J, Cai SX. Discovery of N-(4-methoxyphenyl)-N,2-dimethylquinazolin-4-amine, a potent apoptosis inducer and efficacious anticancer agent with high blood brain barrier penetration. J Med Chem. 2009 Apr 23;52(8):2341-51. doi: 10.1021/jm801315b.

Reference Type BACKGROUND
PMID: 19296653 (View on PubMed)

Kasibhatla S, Baichwal V, Cai SX, Roth B, Skvortsova I, Skvortsov S, Lukas P, English NM, Sirisoma N, Drewe J, Pervin A, Tseng B, Carlson RO, Pleiman CM. MPC-6827: a small-molecule inhibitor of microtubule formation that is not a substrate for multidrug resistance pumps. Cancer Res. 2007 Jun 15;67(12):5865-71. doi: 10.1158/0008-5472.CAN-07-0127.

Reference Type BACKGROUND
PMID: 17575155 (View on PubMed)

Related Links

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http://www.myriadpharma.com

Myriad Pharmaceuticals Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing novel small molecule drugs that address severe medical conditions, including cancer and HIV infection.

Other Identifiers

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MPC-6827-019

Identifier Type: -

Identifier Source: org_study_id