Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Annamycin

Anti-Bacterial Agents

Antibiotics, Antitubercular

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).

Liposomal Annamycin

Robert Shepard, MD

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 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

Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated

Area under the plasma concentration - time curve (AUC) of annamycin and its metabolite, annamycinol

Determined by acute myeloid leukemia (AML) response rate based on the International Working Group (IWG) Response Criteria in AML (Cheson, 2003). Anti-leukemic Activity measured by bone marrow biopsy/aspirate pre and post treatment.

Moleculin Biotech, Inc.

AEs were collected from safety population from the time of study treatment initiation until 39 days after the last dose of study treatment.

Safety population = all participants who received any amount of liposomal annamycin.

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).

100 mg/m2 Dose Level

120 mg/m2 Dose Level

Dose Level 1: 100 mg/m2/Day Liposomal Annamycin

Dose Level 2: 120 mg/m2/Day Liposomal Annamycin

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG grading scale- 0 - Fully active, able to carry on all pre-disease performance without restriction

1- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light of sedentary nature, e.g., light house work, office work 2 - Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4 - Completely disabled. Cannot carry on any self care. Totally confined to bed or chair.

5 - Dead

ECOG Performance Status

Chief Scientific Officer

Dose Level 2 : 120 mg/m2/Day Liposomal Annamycin

Dose-limiting Toxicity

Annamycin 100 mg/m2 - Day 1

Annamycin 100 mg/m2 - Day 3

Annamycin 120 mg/m2 - Day 1

Annamycin 120 mg/m2 - Day 3

Annamycinol 100 mg/m2 - Day 1

Annamycinol 100 mg/m2 - Day 3

Annamycinol 120 mg/m2 - Day 1

Annamycinol 120 mg/m2 - Day 3

One participant excluded from summary statistics due to high Annamycin concentrations

Spots Global Cancer Trial Database for Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial