NCT03787498

A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

A Phase 1b Dose-escalation Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PLX2853 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Opna Bio LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in subjects with Relapsed or Refractory Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

Conditions

• Relapsed Acute Myeloid Leukemia (AML)
• Refractory Acute Myeloid Leukemia (AML)
• High-risk Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	PLX2853	Tablets

Timeline

• Start date: 2019-03-19
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2018-12-26
• Last updated: 2022-04-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study