NCT03315039

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

Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Moleculin Biotech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 standard induction therapy

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
DRUG	Liposomal Annamycin	2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).

Timeline

• Start date: 2018-03-28
• Primary completion: 2020-01-14
• Completion: 2020-06-20
• First posted: 2017-10-19
• Last updated: 2022-03-10
• Results posted: 2022-02-23

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study