APTO-253 for AML & MDS

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Trial Summary

Recruiting

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

Condition

Acute Myelogenous Leukemia in Relapse, Acute Myelogenous Leukemia, Relapsed, Adult, Acute Myelogenous Leukemia, Adult, Acute Myelogenous Leukemia, High Risk Myelodysplasia

Actual Start Date

October 2014

Estimated Primary Completion Date

February 2022

About the Trial

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

This is a multicenter, open-label, Phase Ib 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.

Detailed Info

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 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.

Study Phase

Phase 1

Estimated Enrollment

60

Estimated Primary Completion Date

February 2022

Study Type

Interventional

Interventions

  • Drug: APTO-253

Sponsor

Aptose Biosciences Inc.

Eligibility

Inclusion Criteria

Gender

All

Age

18 years and older

Last dose of chemotherapy

At least 14 days

  • 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

Locations

The following cities have APTO-253 clinical trial sites. Please check back often as locations will be updated.

Enrollment

For more information on enrollment in our current clinical trials, please contact us or visit clinicaltrials.gov for location information.

Contact Us Visit ClinicalTrials.gov

The safety and efficacy of the investigational use of these products have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.