Status:
ACTIVE_NOT_RECRUITING
A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML
Lead Sponsor:
Treadwell Therapeutics, Inc
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04730258
Start Date
April 16 2021
End Date
January 1 2026
Last Update
May 18 2025
Active Locations (9)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
3
Norton Cancer Institute - Saint Matthews
Louisville, Kentucky, United States, 40207
4
New York Presbyterian Weill Cornell Medical Center
New York, New York, United States, 10021