Novel Phase I Dose De-escalation Design Trial to Determine the Biological Modulatory Dose of the Antiangiogenic Agent SU5416
Open Access
- 1 November 2005
- journal article
- Published by American Association for Cancer Research (AACR) in Clinical Cancer Research
- Vol. 11 (21), 7938-7944
- https://doi.org/10.1158/1078-0432.ccr-04-2538
Abstract
Purpose: To determine the biological modulatory dose of SU5416, we employed a novel trial design, where “dose de-escalation” was based on demonstrable biological changes observed at the maximum tolerated dose. If such an effect was shown, dose de-escalation to a predefined dose level would occur to determine if the lower dose exhibited the same amount of pharmacodynamic effect as the higher dose.Keywords
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