Acute Myeloid Leukemia Clinical Trial

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

Summary

This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.

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Full Description

This is a multicenter, open-label, Phase 1 a/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation. This is to be followed by a cohort expansion phase.

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Eligibility Criteria

Key Inclusion Criteria:

Age ≥18 years
Life expectancy of at least 3 months
ECOG Performance Status ≤ 2
Patients must be able to swallow capsules
Adequate hematologic parameters, unless cytopenias are disease caused
Adequate renal, liver and cardiac functions

Key Exclusion Criteria:

Patients with GVHD requiring systemic immunosuppressive therapy
Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
Clinically significant leukostasis
Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study treatment administration

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04477291

Recruitment Status:

Active, not recruiting

Sponsor:

Aptose Biosciences Inc.

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There are 10 Locations for this study

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City of Hope National Medical Center
Duarte California, 91010, United States
University of Southern California
Los Angeles California, 90033, United States
University of Miami
Miami Florida, 33136, United States
Northwestern University
Chicago Illinois, 60611, United States
Ochsner Healthcare
New Orleans Louisiana, 70121, United States
Atlantic Hematological Oncology Center
Morristown New Jersey, 07962, United States
Roswell Park Comprehensive Cancer Center
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
University Hospital of Cleveland
Cleveland Ohio, 44106, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

80

Study ID:

NCT04477291

Recruitment Status:

Active, not recruiting

Sponsor:


Aptose Biosciences Inc.

How clear is this clinincal trial information?

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