This is a phase 2 study of ENMD-2076 in patients with advanced/metastatic soft tissue sarcoma. This study will help to understand how well ENMD-2076 works and how safe and tolerable the drug is in this patient population.
ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
6-month Progression-free Survival Rate (PFS)
Number of patients with no progression of disease at 6 months
Time frame: From start of study treatment until disease progression or death, whichever occurs first, up to 6 months.
Number of and Severity of Adverse Events Per Participant
Number of participants who experienced a grade 3 or higher adverse event. Reporting threshold 5%
Time frame: 2 years
Objective Response Rate
Objective Response Rate (ORR) = CR+ PR. ORR is evaluated per RECIST v1.1 criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Time frame: From start of study treatment until disease progression or death, whichever occurs first.
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