Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
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ClinicalTrials.gov Identifier: NCT03315039 |
Recruitment Status :
Completed
First Posted : October 19, 2017
Results First Posted : February 23, 2022
Last Update Posted : March 10, 2022
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Sponsor:
Moleculin Biotech, Inc.
Information provided by (Responsible Party):
Moleculin Biotech, Inc.
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Leukemia, Myeloid, Acute |
Intervention |
Drug: Liposomal Annamycin |
Enrollment | 7 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | no participants were enrolled in Phase 2 |
Arm/Group Title | Dose Level 1: 100 mg/m2/Day Liposomal Annamycin | Dose Level 2: 120 mg/m2/Day Liposomal Annamycin |
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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). | 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). |
Period Title: Overall Study | ||
Started | 4 | 3 |
Completed | 4 | 3 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Dose Level 1: 100 mg/m2/Day Liposomal Annamycin | Dose Level 2: 120 mg/m2/Day Liposomal Annamycin | Total | |
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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). | 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). | Total of all reporting groups | |
Overall Number of Baseline Participants | 4 | 3 | 7 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 7 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
1 25.0%
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1 33.3%
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2 28.6%
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>=65 years |
3 75.0%
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2 66.7%
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5 71.4%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 4 participants | 3 participants | 7 participants | |
67.0 (6.73) | 57.0 (18.19) | 62.7 (12.71) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 7 participants | |
Female |
1 25.0%
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1 33.3%
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2 28.6%
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Male |
3 75.0%
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2 66.7%
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5 71.4%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 7 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
|
1 33.3%
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1 14.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
|
0 0.0%
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Black or African American |
0 0.0%
|
0 0.0%
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0 0.0%
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White |
4 100.0%
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2 66.7%
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6 85.7%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 4 participants | 3 participants | 7 participants |
4 100.0%
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3 100.0%
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7 100.0%
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ECOG Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 4 participants | 3 participants | 7 participants | |
ECOG - 0 |
0 0.0%
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1 33.3%
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1 14.3%
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ECOG - 1 |
3 75.0%
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1 33.3%
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4 57.1%
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ECOG- 2 |
1 25.0%
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1 33.3%
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2 28.6%
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[1]
Measure Description:
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 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Chief Scientific Officer |
Organization: | Moleculin Biotech Inc |
Phone: | 862-273-1432 |
EMail: | DPicker@moleculin.com |
Responsible Party: | Moleculin Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT03315039 |
Other Study ID Numbers: |
MB-104 |
First Submitted: | October 16, 2017 |
First Posted: | October 19, 2017 |
Results First Submitted: | December 7, 2021 |
Results First Posted: | February 23, 2022 |
Last Update Posted: | March 10, 2022 |