CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Liposomal Annamycindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03315039
NCT03315039Phase 2Completed

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

Moleculin Biotech, Inc.·interventional·Posted Oct 19, 2017·Updated Mar 10, 2022

In Brief

A Phase 2 clinical trial evaluating Liposomal Annamycin for Leukemia, Myeloid, Acute. Completed, enrolled 7 participants across 4 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedOct 19, 2017
Enrollment StartMar 28, 2018
Primary CompletionJan 14, 2020
Study CompletionJun 20, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.7 years ago

Interventions

Liposomal Annamycindrug

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).