A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
NCT ID: NCT02267863
Last Updated: 2022-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2014-10-31
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
APTO-253
APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached.
Interventions
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APTO-253
APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aptose Biosciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rafael Bejar, MD., PhD.
Role: STUDY_DIRECTOR
Aptose Biosciences Inc.
Locations
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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
Countries
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Related Links
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Aptose Biosciences
Other Identifiers
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253-HEM1-01
Identifier Type: -
Identifier Source: org_study_id
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