The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in subjects with advanced hematological malignancies, and to further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
TAK-901 will be administered via IV infusion over a 3-hour period on Days 1,4,8,11,15,18,22, and 25 of each 28-day cycle.
University of Michigan
Ann Arbor, Michigan, United States
To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies.
Time frame: Duration of the study
To further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.
Time frame: Duration of study
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Time frame: Duration of the study
To make a preliminary assessment of the clinical activity of TAK-901.
Time frame: Duration of therapy
To make a preliminary assessment of the effects of TAK-901 on pharmacodynamic biomarkers.
Time frame: Duration of therapy
To make a preliminary assessment of the association between selected genetic markers and TAK-901 response and/or pharmacokinetic parameters.
Time frame: Duration of therapy
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