A Phase Ia/b Dose Escalation and Expansion, Multicenter, Open-label, Safety, Pharmacokinetic and Pharmacodynamic Study of APTO-253 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia or High-Risk Myelodysplasia
Who is this study for? Patients with relapsed or refractory acute myelogenous leukemia or high-risk myelodysplasia
What treatments are being studied? APTO-253
Status: Terminated
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
University of Arizona Cancer Center
Tucson
California
UC San Diego Moores Cancer Center
La Jolla
University of California, Irvine
Orange
Georgia
Emory University; Winship Cancer Institute
Atlanta
Louisiana
Ochsner Cancer Institute
New Orleans
Michigan
University of Michigan
Ann Arbor
Montana
St. Vincent Frontier Cancer Center
Billings
New York
University of Rochester; Wilmot Cancer Institute Clinical Trials Office
Rochester
Ohio
University Hospital
Cleveland
Oregon
Oregon Health & Science University
Portland
South Carolina
Prisma Health, Institute for Translational Oncology Research
Greenville
Texas
Baylor Research Institute
Dallas
MD Anderson Cancer Center
Houston
Time Frame
Start Date: 2014-10
Completion Date: 2021-09
Participants
Target number of participants: 21
Treatments
Experimental: Dose Escalation and Expansion
APTO-253 will be given in ascending doses in patients with relapsed or refractory AML or high risk MDS (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 30 patients enrolled in the expansion cohort at the recommended dose.
Authors
Related Therapeutic Areas
Sponsors
Leads: Aptose Biosciences Inc.