A phase I study of single-agent BEZ235 special delivery system sachet in Japanese patients with advanced solid tumors

ConclusionsAlthough the MTD was not established, the maximum clinically tolerable dose was determined to be 1200  mg because two out of six patients required dose reduction in Cycle 2. The recommended dose was determined to be 1000 mg qd, which was comparable with the results of the first-in-human BEZ235 study in Western patients with advanced solid tumors (NCT00620594). Additionally, the tolerability of BEZ 235 400 mg bid in Japanese oncology patients was confirmed in this study.ClinicalTrials.gov identifierNCT01195376. (Source: Cancer Chemotherapy and Pharmacology)

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