Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Myelogenous Leukemia
  • Acute Myelogenous Leukemia in Relapse
  • Acute Myelogenous Leukemia, Adult
  • Acute Myelogenous Leukemia, Relapsed, Adult
  • High Risk Myelodysplasia
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 patie...

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.

Tracking Information

NCT #
NCT02267863
Collaborators
Not Provided
Investigators
Study Director: Rafael Bejar, MD., PhD. Aptose Biosciences Inc.