The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.
This study will be evaluating the safety and tolerability of CFI-400945 in subjects with Acute Myeloid Leukemia, Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia. The study is designed to build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
Azacitidine will be given at its labeled dose and schedule
City of Hope
Duarte, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, United States
Incidence of treatment emergent AEs
The number of subjects who experience an adverse event that was possibly related to study drug
Time frame: 36 months
Treatment emergent changes in vital signs
The number of subjects who experience changes in blood pressure, heart rate, respiratory rate, body temperature that was possibly related to study drug.
Time frame: 36 months
Treatment emergent changes in clinical laboratory tests
The number of subjects who experience a change in laboratory parameters that was possibly related to study drug.
Time frame: 36 months
Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins
The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug.
Time frame: 36 months
Composite Complete Remission Rate, CRc (complete remission + complete remission with incomplete blood count recovery + complete remission with incomplete platelet count recovery [CR + CRi + CRp])
Response rate will be summarized by dose cohort and overall using the percent of patients in patient with AML
Time frame: 36 months
Overall response rate (ORR, defined as Complete remission + Marrow CR + Partial remission + Hematologic Improvement (CR + mCR+ PR + HI)
Response rate will be summarized by dose cohort and overall using the percent of patients in patients with MDS, CMML
Time frame: 36 months
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New York Presbyterian Weill Cornell Medical Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Centre
Houston, Texas, United States
University of Alberta
Edmonton, Alberta, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Queen Mary Hospital
Hong Kong, Hong Kong
The pharmacokinetics of CFI-400945 will be assessed through AUC.
Area under the plasma concentration (AUC) versus time curve from time 0 to time of least measurable concentration tabulated by dose group.
Time frame: 36 months
To assess the pharmacokinetic profile of CFI-400945 through Cmax.
Cmax will be assessed through the maximum measured plasma concentration occurring at Tmax tabulated by dose group.
Time frame: 36 months
To assess the pharmacokinetic profile of CFI-400945 through T1/2.
Elimination half life will be calculated and tabulated by dose group.
Time frame: 36 months