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)
Facility
City
Region
Status
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
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.
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