drugset
drugset / Trial / NCT03388749

Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)

NCT03388749 ↗

Phase 1/2 Completed 20 enrolled Moleculin Biotech, Inc.
NaSequentialOpen-labelTreatment

Summary

This is a multi-center, open-label, dose escalation study that will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of liposomal annamycin as a single agent for the treatment of subjects with AML that is refractory to or relapsed after induction therapy

Timeline

Start
2018-12-17
Primary completion
2022-02-08
Completion
2022-02-14

Drugs

EvaluationDrugModalityDoseRoute
Subject NAXTARUBICIN Small molecule 120 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 150 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 180 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 210 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 240 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 270 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 300 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 330 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 360 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 390 mg/m2 Intravenous
Subject NAXTARUBICIN Small molecule 420 mg/m2 Intravenous

Indications

acute myeloid leukemia