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Clinical Trial NCT04730258 (TWT-202) for Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML, MDS, CMML is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML (TWT-202) Phase 1, Phase 2 72
Clinical Trial NCT04730258 (TWT-202) is designed to study Treatment for Acute Myeloid Leukemia, Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, AML, MDS, CMML. It is a Phase 1 Phase 2 interventional study that is active, not recruiting, having started on 16 April 2021, with plans to enroll 72 participants. Led by Treadwell Therapeutics, Inc, it is expected to complete by 1 January 2026. The latest data from ClinicalTrials.gov was last updated on 18 May 2025.
Brief Summary
The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.
Detailed Description
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.
Official Title
Phase 1b/2 Clinical Study of the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of CFI-400945 as a Single Agent or in Combination With Azacitidine in Patients With AML, MDS or CMML
Conditions
Acute Myeloid LeukemiaMyelodysplastic SyndromesChronic Myelomonocytic LeukemiaAMLMDSCMMLPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- TWT-202
NCT ID Number
Start Date (Actual)
2021-04-16
Last Update Posted
2025-05-18
Completion Date (Estimated)
2026-01
Enrollment (Estimated)
72
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Active, not recruiting
Keywords
Polo-like kinase 4
PLK4
serine/threonine kinase Polo-like kinase 4
CFI-400945
945
Polo-Like Kinase 4 inhibitors/antagonists
hematologic malignancies
PLK-4
UHN
University Health Network
Treadwell
Treadwell Therapeutics
Treadwell Tx
PLK4
serine/threonine kinase Polo-like kinase 4
CFI-400945
945
Polo-Like Kinase 4 inhibitors/antagonists
hematologic malignancies
PLK-4
UHN
University Health Network
Treadwell
Treadwell Therapeutics
Treadwell Tx
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental1A: Monotherapy escalation and expansion Dose escalation and expansion arm with CFI-400945 | CFI-400945 The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms. |
Experimental2A: Combination escalation and expansion Dose escalation and expansion arm with CFI-400945 and azacitidine | CFI-400945 The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms. Azacitidine Azacitidine will be given at its labeled dose and schedule |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Incidence of treatment emergent AEs | The number of subjects who experience an adverse event that was possibly related to study drug | 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. | 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. | 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. | 36 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | 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 | 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. | 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. | 36 months |
To assess the pharmacokinetic profile of CFI-400945 through T1/2. | Elimination half life will be calculated and tabulated by dose group. | 36 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Patients must be >18 years of age
For Parts 1A and 1B, the following malignancy types will be included:
- Relapsed or refractory AML.
- MDS, after prior hypomethylating agents.
- CMML, with progressive disease/lack of response after hypomethylating agents
For Parts 1A and 1B, Patients may have relapsed or refractory disease.
For Parts 2A and 2B, the following malignancy types will be included:
- Relapsed or Refractory AML.
- MDS patients should be limited to high risk disease
- MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter)
- Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before Cycle 1 Day 1, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks of Cycle 1 Day 1.
- Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.
Treadwell Therapeutics, IncNo contact data.
9 Study Locations in 3 Countries
California
City of Hope, Duarte, California, 91010, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, 95817, United States
Kentucky
Norton Cancer Institute - Saint Matthews, Louisville, Kentucky, 40207, United States
New York
New York Presbyterian Weill Cornell Medical Center, New York, New York, 10021, United States
Ohio
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States
Texas
The University of Texas MD Anderson Cancer Centre, Houston, Texas, 77030, United States
Alberta
University of Alberta, Edmonton, Alberta, T6G2B7, Canada
Ontario
Princess Margaret Cancer Center, Toronto, Ontario, M5G2C1, Canada
Queen Mary Hospital, Hong Kong, Hong Kong