TerminatedPhase 1

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

Stopped: Change in corporate strategy

United States45 participantsStarted 2020-10-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Incidence of treatment-emergent adverse events of CG-806

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Establish a CG-806 dose that maintains a biologically active plasma concentration

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Establish a recommended dose for future development of CG-806

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Trial details

NCT IDNCT04477291

SponsorAptose Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-15

View on ClinicalTrials.gov More Acute Myeloid Leukemia trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of treatment-emergent adverse events of CG-806

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Establish a CG-806 dose that maintains a biologically active plasma concentration

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Establish a recommended dose for future development of CG-806

Timeframe: At the end of Cycle 1 (each cycle is 28 days)