This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
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. Temozolomide at 85 mg/m2 administered orally daily for 21 days in a 4 week cycle.
The Angeles Clinic
Los Angeles, California, United States
Cancer Centers of Florida
Ocoee, Florida, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Safety and Tolerability; Maximum Tolerated Dose
Time frame: After each cohort is enrolled
Pharmacokinetics
Time frame: Cycle 1
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