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Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Azixa
Sponsored by
Myrexis Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma, Brain Neoplasms, Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • Cedars-Sinai Medical Center
  • Stanford University
  • Northwestern University
  • Tufts Medical Center
  • Lahey Clinic
  • University of Massachusettes
  • Darthmouth -Hitchcock Medical Center
  • Columbia University
  • SCCA/University of Washington

Outcomes

Primary Outcome Measures

To determine the progression-free survival (PFS) rate

Secondary Outcome Measures

Overall survival
Overall response rate

Full Information

First Posted
May 3, 2009
Last Updated
October 13, 2011
Sponsor
Myrexis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00892931
Brief Title
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
Official Title
Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Myrexis Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma, Brain Neoplasms, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Azixa
Other Intervention Name(s)
MPC-6827
Intervention Description
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)
Primary Outcome Measure Information:
Title
To determine the progression-free survival (PFS) rate
Time Frame
Six 28-day cycles from start of therapy
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
36 months
Title
Overall response rate
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Beelen, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lawrence Recht, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Massachusettes
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Darthmouth -Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SCCA/University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
981209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19296653
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.
Results Reference
background
PubMed Identifier
17575155
Citation
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.
Results Reference
background
Links:
URL
http://www.myriadpharma.com
Description
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.

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Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme

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