This is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. Three dose levels of MPC-6827 will be administered with carboplatin to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with carboplatin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
MPC-6827 at 2.1mg/m2, 2.7mg/m2 or 3.3mg/m2 administered by intravenous infusion over 2 hours once weekly for three weeks in a 4 week cycle. Carboplatin at AUC4 administered by intravenous infusion over 1 hour on Day 1 of each 4 week cycle.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Emory University
Atlanta, Georgia, United States
Mt. Sinai School of Medicine
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Maximum tolerated dose
Time frame: After each cohort is enrolled and all subjects have completed 1 cycle
Pharmacokinetics
Time frame: Cycle 1 only
Antitumor activity
Time frame: Screening, end of each cycle, end of study
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Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States