Myelodysplastic Syndrome Clinical Trial
A Study of CFI-400945 With or Without Azacitidine or Decitabine in Patients With AML, MDS or CMML
The purpose of this study is to test the safety of an investigational drug called CFI-400945 alone and in combination with azacitidine or decitabine
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.
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.
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There are 8 Locations for this study
Louisville Kentucky, 40207, United States
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