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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    80
  • sponsor
    Aptose Biosciences Inc.
Updated on 30 July 2021
refractory acute myeloid leukemia (aml)
secondary acute myeloid leukemia
acute promyelocytic leukemia

Summary

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.

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.

Details
Condition acute myeloblastic leukemia, Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Acute Myeloid Leukemia, acute myelogenous leukemia, anll
Treatment CG-806
Clinical Study IdentifierNCT04477291
SponsorAptose Biosciences Inc.
Last Modified on30 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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