A Study of APTO-253 in Patients With Relapsed or Refractory AML or MDS
Last updated on July 2021Recruitment
- 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.