Aptose Biosciences Inc.

Luxeptinib for AML

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Trial Summary

Recruiting

- 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.

Condition

Acute Myeloid Leukemia, Myelodysplastic Syndromes

Actual Start Date

October 6, 2020

Estimated Primary Completion Date

November 2023

About the Trial

A Study of Luxeptinib (CG-806) in Patients With Relapsed or Refractory AML

This is a multicenter, open-label, Phase 1 dose escalation study of safety, pharmacodynamics, and pharmacokinetics of luxeptinib in ascending cohorts (3+3 design) to determine the MTD or recommended dose in patients with relapsed or refractory AML. This is to be followed by a cohort expansion phase at the MTD or recommended dose.

Detailed Info

Brief 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.

Study Phase

Phase 1

Estimated Enrollment

80

Estimated Primary Completion Date

November 2023

Study Type

Interventional

Interventions

  • Drug: CG-806

Sponsor

Aptose Biosciences Inc.

Eligibility

Inclusion Criteria

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

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

Locations

The following cities have luxeptinib (CG-806) clinical trial sites. Please check back often as locations will be updated.

Enrollment

For more information on enrollment in our current clinical trials, please contact us or visit clinicaltrials.gov for location information.

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The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.