Endpoints
bleeding, death, neutropenia, febrile neutropenia, toxicity, thrombocytopenia, infection
BLEEDING, NEUTROPENIA, FEBRILE NEUTROPENIA, THROMBOCYTOPENIA, DISEASE, EVENT, BONE MARROW DISEASE, INFECTION, SECONDARY
The primary objective was to estimate the objective response rate. Objective response was assessed using RECIST 1.1. A patient was considered evaluable if they had received at least one dose of palbociclib or ganitumab and had at least one follow‐up disease evaluation of their RECIST measurable disease or evidence of clinical progression.Assessment of toxicity according to the CTCAE v5.0 was another primary objective. Hematologic dose‐limiting toxicity (DLT) criteria included grade 4 thrombocytopenia or grade 4 neutropenia of any duration in the absence of bone marrow disease; or grade 3 or higher febrile neutropenia with or without documentation of infection; or grade 3 thrombocytopenia in association with a grade 2 or higher bleeding episode; or delay in the start of a subsequent cycle by >14 days due to thrombocytopenia or neutropenia in a participant without bone marrow disease.Progression‐free survival (PFS; event defined as first occurrence of relapse, progression, or death from any cause) and overall survival (OS; event defined as death from any cause) were secondary efficacy endpoints, with patients censored at last follow‐up in the absence of an event.