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Active, not recruiting Phase 1/2

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

NCT04730258 · tracked via the Priya Life Science USA tracker
Sponsor
Treadwell Therapeutics, Inc
Phase
Phase 1/2
Started
2021-04-16
Last updated
2025-05-18

Condition(s) studied

Acute Myeloid LeukemiaMyelodysplastic SyndromesChronic Myelomonocytic LeukemiaAMLMDSCMML

Investigational drug(s) / intervention(s)

CFI-400945 →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

Study summary

The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients must be \>18 years of age 2. For Parts 1A and 1B, the following malignancy types will be included: 1. Relapsed or refractory AML. 2. MDS, after prior hypomethylating agents. 3. CMML, with progressive disease/lack of response after hypomethylating agents For Parts 1A and 1B, Patients may have relapsed or refractory disease. 3. For Parts 2A and 2B, the following malignancy types will be included: 1. Relapsed or Refractory AML. 2. MDS patients should be limited to high risk disease 3. MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease; 4. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol. 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: 1. Patients who have received investigational therapy, radiotherapy, immunotherapy, monoclonal antibodies, or chemotherapy within 14 days or 5 half-lives (whichever is shorter) 2. 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. 3. Any Grade ≥ 2 persistent non-hematological toxicity related to allogeneic transplant, such as those requiring systemic immunosuppressive therapy.

Primary outcome measure(s)

  • Incidence of treatment emergent AEs — 36 months
    The number of subjects who experience an adverse event that was possibly related to study drug
  • Treatment emergent changes in vital signs — 36 months
    The number of subjects who experience changes in blood pressure, heart rate, respiratory rate, body temperature that was possibly related to study drug.
  • Treatment emergent changes in clinical laboratory tests — 36 months
    The number of subjects who experience a change in laboratory parameters that was possibly related to study drug.
  • Treatment emergent changes in physical examinations, ECOG performance status, electrocardiograms (ECGs), echocardiograms and cardiac troponins — 36 months
    The number of subjects who experience changes in physical examinations, performance status, ECG, troponins that were possibly related to study drug.

Trial sites (9)

FacilityCityRegionStatus
City of Hope Duarte California
University of California Davis Comprehensive Cancer Center Sacramento California
Norton Cancer Institute - Saint Matthews Louisville Kentucky
New York Presbyterian Weill Cornell Medical Center New York New York
The Ohio State University Comprehensive Cancer Center Columbus Ohio
The University of Texas MD Anderson Cancer Centre Houston Texas
University of Alberta Edmonton Alberta
Princess Margaret Cancer Center Toronto Ontario
Queen Mary Hospital Hong Kong Hong Kong

More Treadwell Therapeutics, Inc trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04730258 on ClinicalTrials.gov ↗ ← All trials in the USA