A Phase 1 interventional study of CG-806 in Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Aptose Biosciences Inc.. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Aptose Biosciences Inc. · Phase 1, Interventional, and Treatment
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.
5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.
This study's enrollment of 45 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.
Browse Leukemia studies →Aptose Biosciences Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: CG-806
CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.
Incidence of treatment-emergent adverse events of CG-806
Patients will be assessed for adverse events during all cycles of treatment and for dose limiting toxicities in Cycle 1 (28-days). Dose escalation to a higher dose level will be considered if none of the first three patients who complete Cycle 1 (28-days) at a given dose level experience a dose limiting toxicity or if only 1 of 6 patients at a given dose level experience a dose-limiting toxicity.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Establish a CG-806 dose that maintains a biologically active plasma concentration
To determine the dose of CG-806 given orally every 12 hours daily that maintains a biologically active plasma concentration during 28-day cycles.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Establish a recommended dose for future development of CG-806
To establish the maximum tolerated dose and/or recommended Phase 2 dose (RP2D) of CG-806 for future clinical trials in patients with AML and other advanced myeloid malignancies.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including maximum plasma concentration (Cmax).
Pharmacokinetics variables including maximum plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including minimum plasma concentration (Cmin)
Pharmacokinetics variables including minimum plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including area under the curve (AUC)
Pharmacokinetics variables including plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including volume of distribution
Pharmacokinetics variables including plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including clearance
Pharmacokinetics variables including plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetics variables including plasma half-life.
Pharmacokinetics variables including plasma concentration at various timepoints.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.
To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, evaluations
To assess patients for evidence of anti-tumor activity of CG-806 based on hematologic, bone marrow, physical examination, and FDG PET-CT imaging evaluations.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
Compare G1 to G3 pharmacokinetics variables including maximum plasma concentration (Cmax)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
Compare G1 to G3 Pharmacokinetics variables including minimum plasma concentration (Cmin)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18 patients on Cycle 1 Day -3 compared to Generation 1 formulation of study drug given to patients during Cycle 1.
Compare G1 to G3 Pharmacokinetics variables including area under the curve (AUC)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18
Compare G1 to G3 Pharmacokinetics variables including volume of distribution
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To determine the Relative Bioavailability of Generation 3 formulation given to up to 18
Compare G1 to G3 Pharmacokinetics variables including clearance
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Compare G1 to G3 Pharmacokinetics variables including clearance
Compare G1 to G3 Pharmacokinetics variables including plasma half-life.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Plan to share: No
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This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Aptose Biosciences Inc.