The purpose of this study is to determine safety, tolerability, dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of ZEN003365 in patients with relapsed/refractory lymphoproliferative malignancies (LPM) or relapsed/refractory acute myeloid leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Dose escalation stage - The safety of orally administered ZEN003365, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose escalation stage - To characterize the DLTs of orally administered ZEN003365, using NCI CTCAE v4.03
Time frame: The first 25 days of at least 12 doses of ZEN003365
Dose expansion stage - Preliminary evidence of the antitumor activity of orally administered ZEN003365 in selected patients, assessed by objective response, duration of objective response and progression-free survival
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - The safety of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, assessed by frequency of adverse events, including worsening of medical conditions/diseases
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose escalation stage - To characterize the pharmacokinetics (PK) of orally administered ZEN003365 in patients, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Time frame: From Day 1 Cycle 1 through the last day of treatment with ZEN003365 (12 weeks, average)
Dose expansion stage - To characterize the PK of orally administered ZEN003365, at the dose chosen based upon the dose escalation stage, using the following parameters: AUC, Tmax, Cmax, Cmin, pre-dose concentration, and accumulation ratio
Time frame: From Screening Visit through 40 days after the last day of treatment with ZEN003365 (19 weeks, average)
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