Assessments
tumor
ONCOLOGY, DISEASE PROGRESSION, TUMOR
Baseline evaluations included medical history, a physical examination, Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) tumor imaging with computed tomography (CT), bone scan, laboratory tests (hematology, blood chemistry), a serum pregnancy test for females of child-bearing potential, and an electrocardiogram with QTc measurement. In the dose confirmation cohort (phase Ib), the response to EC was evaluated every 6 weeks until disease progression according to the investigator, based on objective tumor assessments using RECIST version 1.1 criteria. In the dose-expansion cohort (phase II), response to EC was evaluated after study start, then every 9 weeks until end of study therapy.