An open-label Phase 1/2a study of BAL101553 adminis-tered as 48-hour intravenous infusions in adult patients with advanced solid tumors
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abstract
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The primary objectives of this study are to determine the maximum
tolerated dose (MTD) and to characterize dose-limiting toxicities
(DLTs) of BAL101553, administered as an intravenous (IV) infusion
over 48 hours on study Days 1, 8 and 15 of a 28-day treatment cycle,
to adults with ad-vanced or recurrent solid tumors who have failed
standard therapy or for whom no effective standard therapy is
avail-able. Secondary objectives: To evaluate the safety and
tolerabil-ity of BAL101553 administered as a 48-hour continuous IV
infusion. To assess the anti-tumor activity of BAL101553
adminis-tered as a 48-hour continuous IV infusion. To assess the
bioavailability of daily oral BAL101553 when administered on study
Days 15–21 of Cycle 2. Exploratory objectives: To assess the
use of biomarkers to characterize the phar-macodynamic effects of
BAL101553,administered as a 48-hour continuous IV infusion. To
explore the potential utility of biomarkers in blood and/or tumor
tissue as predictive biomarkers.
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type of project
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clinical studies
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status
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ongoing - recruiting phase
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start of project
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2016
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end of project
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2018
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study design
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Phase I / II
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responsible person
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PD Dr. med. Markus Jörger
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