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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


Description

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

Trial Eligibility

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.

Study Info

Organization

Treadwell Therapeutics, Inc


Primary Outcome

Incidence of treatment emergent AEs


Outcome Timeframe 36 months

NCTID NCT04730258

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2021-04-16

Completion Date 2026-01

Enrollment Target 72

Interventions

DRUG CFI-400945

DRUG Azacitidine

Locations Recruiting

City of Hope

United States, California, Duarte


University of California Davis Comprehensive Cancer Center

United States, California, Sacramento


Norton Cancer Institute - Saint Matthews

United States, Kentucky, Louisville


New York Presbyterian Weill Cornell Medical Center

United States, New York, New York


The Ohio State University Comprehensive Cancer Center

United States, Ohio, Columbus


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