SCH52365: PHASE I STUDY OF CYCLIC ORAL ADMINISTRATION

$16,409M01FY2000RRNIH

University Of Texas Hlth Sci Ctr San Ant, San Antonio TX

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Abstract

SCH 52365 (Temodal) is an oral alkylating agent of the imidazotetrazine derivative group which exhibits broad spectrum antitumor activity and better toxicity profile than similar compounds. It has been demonstrated in murine tumors that Temodal's activity is schedule dependent with higher activity demonstrated using a daily schedule for 5 consecutive days. On this schedule the compound produced significant increases in survival time of leukemia or lymphoma bearing mice. Temodal has also undergone previous Phase I studies in adult and pediatric patients and phase II studies in patients with gioblastoma multiforme. This study is open label, rising multiple-dose Phase I and is designed to characterize the safety profile and to determine the MTD and DLT of SCH 52365 when administered orally to cancer patients using a modified dosing regimen.

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