A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done to evaluate the safety and effectiveness of APTO-253 for the treatment of patients with the condition of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) for which either the standard treatment has failed, is no longer effective, or can no longer be administered safely or poses a risk for your general well being.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aptose Biosciences Inc.

Criteria

Inclusion Criteria:

• Patients ≥18 years old

• Life expectancy of at least 2 months

• Off previous cancer therapy for at least 14 days, or 5 half-lives for noncytotoxic agents prior to first study treatment administration

• Patients must have a calculated creatinine clearance >60 mL/min

• Acceptable hematologic, renal and liver functions and coagulation status parameters

Exclusion Criteria:

• Patients with GVHD requiring systemic immunosuppressive therapy

• Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinical significant disease related metabolic disorder

• Clinically significant intravascular coagulation

• Treatment with other investigational drugs within 14 days prior to first study treatment administration