Myelodysplastic Syndrome Clinical Trial

A Study of CFI-400945 With or Without Azacitidine in Patients With AML, MDS or CMML

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

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Full 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 build on encouraging data from another study and to obtain further safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) data of CFI-400945.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04730258

Recruitment Status:

Recruiting

Sponsor:

Treadwell Therapeutics, Inc

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There are 8 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
Paul Koller
Contact
Felicia Lewis
Contact
[email protected]
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Brian Jonas, MD
Contact
[email protected]
Linh Dang-Chu
Contact
[email protected]
Norton Cancer Institute - Saint Matthews
Louisville Kentucky, 40207, United States
New York Presbyterian Weill Cornell Medical Center
New York New York, 10021, United States More Info
Gail Roboz
Contact
Ameenah Sukkur
Contact
[email protected]
The Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Alice Mims
Contact
Stacey Dillon
Contact
[email protected]
The University of Texas MD Anderson Cancer Centre
Houston Texas, 77030, United States More Info
Gautam Borthakur
Contact
[email protected]
University of Alberta
Edmonton Alberta, T6G2B, Canada More Info
Joseph Brandwein
Contact
Brent Howie
Contact
[email protected]
Princess Margaret Cancer Center
Toronto Ontario, M5G2C, Canada More Info
Karen Yee
Contact
Hong Song
Contact
[email protected]
Queen Mary Hospital
Hong Kong , , Hong Kong More Info
Keith Chi Yeung Fung
Contact
[email protected]
Anskar Leung
Contact

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04730258

Recruitment Status:

Recruiting

Sponsor:


Treadwell Therapeutics, Inc

How clear is this clinincal trial information?

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