Treatment Program
tumor, death, Tumor, Cancer
TUMOR, TUMOR, ADVERSE EVENT, BLOOD, CANCER
This was a multi-center, phase Ib dose escalation study with a 3 + 3 design conducted at 2 Harvard Cancer Center sites, namely Dana-Farber Cancer Institute/Brigham Cancer Center and Massachusetts General Hospital (Diagram of patients enrolled.Radiologic tumor assessments included contrast-enhanced CT scan of the chest, abdomen and pelvis or MRI abdomen, and pelvis with contrast-enhanced CT chest. Radiologic response was classified according to RECISTv1.1. Tumor markers, carcinoembryonic antigen (CEA) and CA 19-9, were followed every 4 weeks, or at the initiation of each chemotherapy cycle. Patients were followed for 6 months after removal from protocol therapy or until death, whichever occurred first. Participants removed from protocol therapy for unacceptable adverse event(s) were followed until resolution or stabilization of the adverse event.Blood samples were taken to assess circulating HGF measurements on day 1 of cycles 1 and 2. The Viracor Eurofins Clinical diagnostics plasma assay for quantification of HGF is a sandwich ELISA performed in a microtiter plate format. A standard curve is used to calculate the concentration of HGF in each test sample. The assay range is 0.6-24 ng/mL.Pre-treatment tissue biopsies, which consisted of 2 needle cores for formalin-fixation, paraffin embedding, were collected to analyze pre-treatment histology and c-Met pathway activation. Initial analysis by immunohistochemistry (IHC) of HGF, c-MET, and p-MET was performed to assess presence of direct targets of ficlatuzumab.