Clinical Trials /

A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

NCT04477291

Description:

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

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of CG-806 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
  • Official Title: A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: APTO-CG-806-03
  • NCT ID: NCT04477291

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
CG-806Dose Escalation and Expansion

Purpose

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

Detailed 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, or therapy-related AML 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 at the candidate
      recommended Phase 2 dose.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation and ExpansionExperimentalDose Escalation and Expansion; CG-806 will be given orally in ascending doses in patients with relapsed or refractory AML (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.
  • CG-806

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 within 14 days prior to first study
             treatment administration
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of treatment-emergent adverse events of CG-806
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Pharmacokinetics variables including maximum plasma concentration (Cmax)
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including maximum plasma concentration (Cmax)
Measure:Pharmacokinetics variables including minimum plasma concentration (Cmin)
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including minimum plasma concentration (Cmin)
Measure:Pharmacokinetics variables including area under the curve (AUC)
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including area under the curve (AUC)
Measure:Pharmacokinetics variables including volume of distribution
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including volume of distribution
Measure:Pharmacokinetics variables including clearance
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including clearance
Measure:Pharmacokinetics variables including serum half-life
Time Frame:At the end of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:Pharmacokinetics variables including serum half-life
Measure: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)
Safety Issue:
Description: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.
Measure: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)
Safety Issue:
Description:To determine the ability of CG-806 to modulate the expression or activity of pharmacodynamic biomarkers of drug effect.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Aptose Biosciences Inc.

Trial Keywords

  • CG-806
  • Aptose
  • FLT3
  • FLT3-ITD
  • D835Y
  • F691L
  • BTK
  • C481S
  • TP53
  • NRAS
  • IDH1
  • BCL2
  • Gilteritinib
  • Quizartinib
  • Midostaurin
  • Crenolanib
  • Venetoclax
  • Ibrutinib
  • Acalabrutinib
  • Zanubrutinib
  • LOXO-305
  • ARQ 531
  • AML
  • Acute Myeloid Leukemia
  • MDS
  • Myelodysplastic Syndrome
  • CLL
  • Chronic Lymphocytic Leukemia
  • Resistant
  • Refractory
  • Relapsed
  • Intolerant
  • Kinase Inhibitor
  • Non covalent

Last Updated

July 15, 2020