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.
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.
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
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There are 10 Locations for this study
Duarte California, 91010, United States More Info
Principal Investigator
Fullerton California, 92835, United States
Miami Florida, 33136, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
New Orleans Louisiana, 70121, United States More Info
Principal Investigator
Morristown New Jersey, 07962, United States More Info
Principal Investigator
Buffalo New York, 14263, United States More Info
Principal Investigator
New York New York, 10065, United States More Info
Principal Investigator
Cleveland Ohio, 44106, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
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