PHASE I STUDY OF CYCLIC ORAL ADMINISTRATION OF SCH61365 (21 OF 28 DAYS)

点击翻译按钮获取中文摘要

SCH 52365 (Temodal) is an oral alkylating agent of the imidazotetrazine derivative group which exhibits broad spectrum antitumor activity and a better toxicity profile than similar compounds. Administration of Temodal results in decreased alkytransferase (ATase) activity within 4 hours of an oral dose and persists in tisues for at least 24 hours. Daily administration in previous trials resulted in progressive depletion of ATase activity over the 5 day treatment course. Thus on each day, it is hypothesized that there would be increased sensitivity to the cytoxic effects of the drug resulting from the decrease in ATase activity induced by the prior day's chemotherapy. This open label, rising multiple-dose Phase I study is designed to characterize the safety profile and to determine the MTD and DLT of SCH52365 when administered orally to cancer patients using a modified dosing regimen.