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

Brief Title

A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS

Official Title

A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes

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.
    

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, 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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Incidence of treatment-emergent adverse events of CG-806

Secondary Outcome

 Pharmacokinetics variables including maximum plasma concentration (Cmax).

Condition

Acute Myeloid Leukemia

Intervention

CG-806

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

80

Start Date

October 6, 2020

Completion Date

June 2024

Primary Completion Date

November 2023

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 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Rafael Bejar, MD, PhD, 858-275-6359, [email protected]

Location Countries

United States

Location Countries

United States

NCT ID

NCT04477291

Organization ID

APTO-CG-806-03

Responsible Party

Sponsor

Study Sponsor

Aptose Biosciences Inc.

Study Sponsor

Rafael Bejar, MD, PhD, Study Director, Aptose Biosciences Inc.

Verification Date

March 2022