Patients
ONCOLOGY, SOLID TUMORS
This study enrolled adult patients with histologically or cytologically confirmed, locally advanced or metastatic solid tumors for whom no effective standard treatment was available. Patients were required to have: an Eastern Cooperative Oncology Group performance status of 0 or 1; a left ventricular ejection fraction ≥ 50%, as measured by echocardiogram or multiple gated acquisition scan; and adequate bone marrow reserve, and renal and hepatic function (absolute neutrophil count ≥ 1.5 × 10The study was conducted in accordance with the protocol, the ethical principles that have their origin in the Declaration of Helsinki, in accordance with the International Conference on Harmonisation Good Clinical Practice standards and applicable regulatory requirements, and in compliance with the Institutional Review Board regulations stated in the Good Clinical Practice regulations and guidelines. All patients provided written informed consent. The trial was designed in accordance with US Food and Drug Administration (FDA) guidelines on bioavailability and bioequivalence studies [