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

Stopped early · Phase 1

Conditions studied: Acute Myelogenous Leukemia in Relapse, Acute Myelogenous Leukemia, Relapsed, Adult, Acute Myelogenous Leukemia, Adult, Acute Myelogenous Leukemia, High Risk Myelodysplasia

In brief

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.

Key facts

Study ID

NCT02267863

Run by

Aptose Biosciences Inc.

People needed

21

Starts

2014-10-01

Expected to finish

2021-09-01

Last updated by the study team

2022-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• University of California, Irvine — Orange, California, United States
• Emory University; Winship Cancer Institute — Atlanta, Georgia, United States
• Ochsner Cancer Institute — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• St. Vincent Frontier Cancer Center — Billings, Montana, United States
• University of Rochester; Wilmot Cancer Institute Clinical Trials Office — Rochester, New York, United States
• University Hospital — Cleveland, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Prisma Health, Institute for Translational Oncology Research — Greenville, South Carolina, United States
• Baylor Research Institute — Dallas, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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