To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
INCB007839 100 or 200 mg/dose as IR capsules
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Baltimore, Maryland, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Nashville, Tennessee, United States
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Time frame: Baseline through study completion
Evaluation of response rates as measured by RECIST criteria
Time frame: At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response
Time frame: Baseline and every visit through study termination
Evaluation of PD markers for HER2 and ErbB ligand levels
Time frame: Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
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