This is a Phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) will receive investigational study drug ARRY-614. This study has 2 parts. In the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Approximately 50 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Completed).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
Moffitt Cancer Center
Tampa, Florida, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Cleveland Clinic
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Establish the maximum tolerated dose (MTD) of study drug.
Time frame: Part 1, 9 months
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1, 9 months; Part 2, 9 months
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time frame: Part 1, 9 months; Part 2, 9 months
Assess the efficacy of the study drug in terms of response, time to response, duration of response, overall survival, hematologic improvement and platelet transfusion independence/reduction.
Time frame: Part 1, 9 months; Part 2, 9 months
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