Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Deepa Jeyakumar

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 Ib 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 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.

Keywords

Acute Myelogenous Leukemia in RelapseAcute Myelogenous Leukemia, Relapsed, AdultAcute Myelogenous Leukemia, AdultAcute Myelogenous LeukemiaHigh Risk MyelodysplasiaAMLMDSLeukemiaAcute Myeloid LeukemiaAptoseAPTO-253Kinase InhibitorLeukemia, MyeloidLeukemia, Myeloid, AcuteMyelodysplastic SyndromesPreleukemiaDose 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

  • University of California, Irvineaccepting new patients
    OrangeCalifornia92868United States
  • University of Arizona Cancer Centeraccepting new patients
    TucsonArizona85724United States

Lead Scientist

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