A Phase 1/2 interventional study of CFI-400945 and Azacitidine in Acute Myeloid Leukemia, Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia, sponsored by Treadwell Therapeutics, Inc. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Treadwell Therapeutics, Inc · Phase 1/2, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 72 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Treadwell Therapeutics, Inc is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
For Parts 1A and 1B, the following malignancy types will be included:
For Parts 1A and 1B, Patients may have relapsed or refractory disease.
For Parts 2A and 2B, the following malignancy types will be included:
Exclusion Criteria:
Dose escalation and expansion arm with CFI-400945
Drug: CFI-400945
Dose escalation and expansion arm with CFI-400945 and azacitidine
Drug: CFI-400945 · Drug: Azacitidine
The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
Also known as: CFI-400945 fumarate, 945, 400945
Azacitidine will be given at its labeled dose and schedule
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
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
Plan to share: No — It is too early to determine whether we will make IPD available - we do not yet have a process written on this. Field will be updated once our policy / process is written.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Treadwell Therapeutics, Inc