Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892931
• Other study ID #: MPC-6827-019
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2009
• Last updated: October 13, 2011
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2011
• Source: Myrexis Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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)

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Darthmouth -Hitchcock Medical Center	Lebanon	New Hampshire
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Columbia University	New York	New York
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	SCCA/University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California
United States	University of Massachusettes	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Myrexis Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the progression-free survival (PFS) rate		Six 28-day cycles from start of therapy	No
Secondary	Overall survival		36 months	No
Secondary	Overall response rate		18 months	No