An early phase II clinical study of YM 294 (rhlL-11) in patients with solid tumors and malignant lymphoma

摘要

An early phase II study was conducted to examine the efficacy and safety of YM 294 on chemotherapy-induced thrombocytopenia in patients with solid tumors and malignant lymphoma. The response rates which were judged as having good or excellent efficacy by the investigators were 66.7% in all groups with 25 microg/kg or more, and the increase in nadir platelet counts and decrease in platelet transfusions were observed. Adverse reactions were fever, edema, abnormal electrocardiogram and weight gain. All adverse reactions as well as abnormal changes in laboratory values for which the casual relationship with the study drug could not be excluded were resolved and proved to be not serious. The results of this study suggest the efficacy of YM 294 at 25 microg/kg or more for chemotherapy-induced thrombocytopenia in patients with solid tumors and malignant lymphoma. It was considered that a study should be performed to assess the efficacy and safety of YM 294 using a dose of 25 microg/kg or more in the future.