A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
Reason given: Change in corporate strategy
Key facts
- Where
- Buffalo, Chicago, Cleveland, Duarte, Houston, Los Angeles, Miami, Morristown, New Orleans, and New York, United StatesSee the 10 sites
- Phase
- Phase 1
Where in United States
- Roswell Park Comprehensive Cancer CenterBuffalo, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- University Hospital of ClevelandCleveland, United StatesNo longer taking part
- City of Hope National Medical CenterDuarte, United StatesNo longer taking part
- University of Texas - MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- University of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- University of MiamiMiami, United StatesNo longer taking part
- Atlantic Hematological Oncology CenterMorristown, United StatesNo longer taking part
- Ochsner HealthcareNew Orleans, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
Trial details
- Who runs it
- Aptose Biosciences Inc.
- Trial code
- NCT04477291
- Record updated
- 7 March 2025
- Original description
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.Read full original descriptionShow less
A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes
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.
Inclusion: 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.
Exclusion: Patients with GVHD requiring systemic immunosuppressive therapy; 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; Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder; Clinically significant leukostasis.