Project
An open-label Phase 1/2a study of BAL101553 adminis-tered as 48-hour intravenous infusions in adult patients with advanced solid tumors
Automatically Closed · 2016 until 2018
Jörger Markus
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Brief description/objective
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.