NCT02732184

A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

A Phase 2 Dose-Escalation Study of AEB1102 (Co-ArgI-PEG) in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome Refractory to Hypomethylating Agents

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Aeglea Biotherapeutics · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Co-ArgI-PEG modified human arginase I

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-04-08
• Last updated: 2018-10-17

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study