This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
This study consists of three sequential parts. Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle. Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2.
The University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States
To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion.
Time frame: 12 months
To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects.
Time frame: 12 months
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Time frame: 12 months
To evaluate disease response.
Time frame: 12 months
To investigate the effect of TAK-901 on tumor proliferation.
Time frame: 12 months
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