This is a multicenter, 2-part, Phase 1 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of TAS1440 administered as a single agent and in combination with all-trans retinoic acid (ATRA) in participants with acute myeloid leukemia (AML) who have relapsed or are refractory (r/r) to prior treatment. The study duration is expected to be approximately 30 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Form: Capsule or Tablet Route of Administration: Oral
Form: Capsule or Tablet Route of Administration: Oral
University of Arizona Cancer Center Site#127
Tucson, Arizona, United States
Norton Cancer Institute Site# 108
Louisville, Kentucky, United States
University of Michigan Medical School Site#107
Ann Arbor, Michigan, United States
Oregon Health and Science University Site#111
Safety: Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Approximately 30 months
Response rate: Number of participants with complete remission (CR), complete remission with incomplete blood count recovery (CRi), partial remission (PR) and complete remission with partial hematological recovery (CRh)
Time frame: Approximately 30 months
Overall survival: Time from the date of the first dose until death due to any cause
Time frame: Approximately 30 months
Pharmacokinetic parameter: Area under the curve (AUC)
Time frame: Up to Day 8 of Cycle 1 and Cycle 2 (28 days per cycle)
Pharmacokinetic parameter: Maximum plasma concentration (Cmax)
Time frame: Up to Day 8 of Cycle 1 and Cycle 2 (28 days per cycle)
Pharmacokinetic parameter: Minimum plasma concentration (Cmin)
Time frame: Up to Day 8 of Cycle 1 and Cycle 2 (28 days per cycle)
Pharmacokinetic parameter: Time to reach maximum plasma concentration (Tmax)
Time frame: Up to Day 8 of Cycle 1 and Cycle 2 (28 days per cycle)
Pharmacokinetic parameter: Half-life (t1/2)
Time frame: Up to Day 8 of Cycle 1 and Cycle 2 (28 days per cycle)
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Portland, Oregon, United States
Fox Chase Cancer Center Site#112
Philadelphia, Pennsylvania, United States
Baylor Scott & White Research Institute Site#110
Dallas, Texas, United States
MD Anderson Cancer Center Site#101
Houston, Texas, United States
Fred Hutchinson Cancer Research Center Site#105
Seattle, Washington, United States