A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
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.
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.
Incidence of treatment-emergent adverse events of CG-806
Pharmacokinetics variables including maximum plasma concentration (Cmax).
Acute Myeloid Leukemia
Study Arms / Comparison Groups
Dose Escalation and Expansion
Description: Dose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML or higher-risk MDS (escalation cohort), until the maximum tolerated dose or candidate recommended Phase 2 dose is reached. Followed up by up to 50 patients enrolled in the expansion cohort at the recommended dose.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
October 6, 2020
Primary Completion Date
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
18 Years - N/A
Accepts Healthy Volunteers
Rafael Bejar, MD, PhD, 858-275-6359, [email protected]
Aptose Biosciences Inc.
Rafael Bejar, MD, PhD, Study Director, Aptose Biosciences Inc.