Clinical trial NCT00892931: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma
Brain Neoplasms
Recurrence
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-05
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To determine the progression-free survival (PFS) rate
timeFrame: Six 28-day cycles from start of therapy
Secondary outcomes:
measure: Overall survival
timeFrame: 36 months
measure: Overall response rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusettes
state: Massachusetts
city: Lebanon
country: United States
facility: Darthmouth -Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University
state: New York
city: Seattle
country: United States
facility: SCCA/University of Washington
state: Washington
Study officials:
affiliation: Myrexis Inc.
name: Andrew Beelen, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Lawrence Recht, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.