Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Official Title

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 or Decitabine in Patients With AML, MDS or CMML

Details

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.

Keywords

Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia AML MDS CMML Polo-like kinase 4 PLK4 serine/threonine kinase Polo-like kinase 4 CFI-400945 945 Polo-Like Kinase 4 inhibitors/antagonists hematologic malignancies PLK-4 UHN University Health Network Treadwell Treadwell Therapeutics Leukemia Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Azacitidine Decitabine

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Patients must be >18 years of age
  2. For Parts 1A and 1B, the following malignancy types will be included:
  3. Relapsed or refractory AML.
  4. MDS, after prior hypomethylating agents.
  5. CMML, with progressive disease/lack of response after hypomethylating agents

For Parts 1A and 1B, Patients may have relapsed or refractory disease.

  1. For Parts 2A and 2B, the following malignancy types will be included:
  2. Relapsed or Refractory AML.
  3. MDS patients should be limited to high risk disease
  4. MDS or CMML should be previously untreated and patients with AML may have relapsed or refractory disease;
  5. Have clinically acceptable laboratory screening results (i.e., clinical chemistry, hematology, and urinalysis) within certain limits per protocol.
  6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You CAN'T join if...

  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.

Locations

  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • The University of Texas MD Anderson Cancer Centre accepting new patients
    Houston Texas 77030 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Treadwell Therapeutics, Inc
Links
Sign up for this study
ID
NCT04730258
Phase
Phase 1/2
Study Type
Interventional
Last Updated