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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Tracking Information | |||||
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First Submitted Date ICMJE | October 16, 2017 | ||||
First Posted Date ICMJE | October 19, 2017 | ||||
Results First Submitted Date ICMJE | December 7, 2021 | ||||
Results First Posted Date ICMJE | February 23, 2022 | ||||
Last Update Posted Date | March 10, 2022 | ||||
Actual Study Start Date ICMJE | March 28, 2018 | ||||
Actual Primary Completion Date | January 14, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Dose-limiting Toxicity [ Time Frame: Day 28 ] Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
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Original Primary Outcome Measures ICMJE |
Dose-limiting Toxicity [ Time Frame: Day 21 ] Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) | ||||
Official Title ICMJE | 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 | ||||
Brief 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 | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia, Myeloid, Acute | ||||
Intervention ICMJE | 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).
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Study Arms ICMJE | Experimental: 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).
Intervention: Drug: Liposomal Annamycin
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
7 | ||||
Original Estimated Enrollment ICMJE |
33 | ||||
Actual Study Completion Date ICMJE | June 20, 2020 | ||||
Actual Primary Completion Date | January 14, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03315039 | ||||
Other Study ID Numbers ICMJE | MB-104 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Moleculin Biotech, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Moleculin Biotech, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Moleculin Biotech, Inc. | ||||
Verification Date | February 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |