Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

NCT00892931 | Completed Phase 2

• 1 other identifier: MPC-6827-019
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma; Brain Neoplasms; Recurrence

Outcome Measures

Primary Outcomes (1)

• To determine the progression-free survival (PFS) rate

  Six 28-day cycles from start of therapy

Secondary Outcomes (2)

• Overall survival

  36 months

• Overall response rate

  18 months

Interventions

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)

Also known as: MPC-6827

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myrexis Inc.: lead

Study Sites (10)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

University of Massachusettes

Worcester, Massachusetts, 01655, United States

Location

Darthmouth -Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Columbia University

New York, New York, 10032, United States

Location

SCCA/University of Washington

Seattle, Washington, 981209, United States

Location

Related Publications (2)

• 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.

  PMID: 19296653 BACKGROUND

• 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.

  PMID: 17575155 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Recurrence

Interventions

verubulin

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Beelen, MD

  Myrexis Inc.

  STUDY DIRECTOR

• Lawrence Recht, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2009
• First Posted: May 5, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 14, 2011

Record last verified: 2011-10

Locations

US (10)