Status:
TERMINATED
A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
Lead Sponsor:
Aptose Biosciences Inc.
Conditions:
Acute Myelogenous Leukemia in Relapse
Acute Myelogenous Leukemia, Relapsed, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
This is a multicenter, open-label, Phase Ia/b dose escalation study of safety, pharmacodynamics, and pharmacokinetics of APTO-253 in ascending cohorts (3+3 design) to determine the MTD or recommended ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT02267863
Start Date
October 1 2014
End Date
September 1 2021
Last Update
August 22 2022
Active Locations (13)
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1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093-0698
3
University of California, Irvine
Orange, California, United States, 92868
4
Emory University; Winship Cancer Institute
Atlanta, Georgia, United States, 30322