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

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.

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

Additional locations may be listed on ClinicalTrials.gov for NCT02267863.

See trial information on ClinicalTrials.gov for a list of participating sites.

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 dose in patients with relapsed or refractory acute

myelogenous leukemia (AML) or high-risk MDS patients. This is to be followed by a cohort

expansion phase at the MTD or recommended dose.

Trial PhasePhase I

Trial Typetreatment

Lead OrganizationAptose Biosciences

Primary ID253-HEM1-01
Secondary IDsNCI-2014-02507
ClinicalTrials.gov IDNCT02267863

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

Inclusion Criteria

Exclusion Criteria

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

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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