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

a study on Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
by Dimitrios Tzachanis, MD, PhD (ucsd)Deepa Jeyakumar, MD (uci)
Photo of Dimitrios Tzachanis
Dimitrios Tzachanis

Description

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.

Official Title

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

Details

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.

Keywords

Acute Myelogenous Leukemia in Relapse Acute Myelogenous Leukemia, Relapsed, Adult Acute Myelogenous Leukemia, Adult Acute Myelogenous Leukemia High Risk Myelodysplasia AML MDS Leukemia Acute Myeloid Leukemia Aptose APTO-253 Kinase Inhibitor Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Dose Escalation and Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

  • UC San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093-0698 United States
  • University of California, Irvine accepting new patients
    Orange California 92868 United States

Lead Scientists at University of California Health

  • Dimitrios Tzachanis, MD, PhD (ucsd)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 45 research publications.
  • Deepa Jeyakumar, MD (uci)
    Associate Clinical Professor, Medicine. Authored (or co-authored) 9 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aptose Biosciences Inc.
Links
Aptose Biosciences
ID
NCT02267863
Phase
Phase 1
Study Type
Interventional
Last Updated