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Study of Liposomal Annamycin for the Treatment of Subjects With Soft-Tissue Sarcomas (STS) With Pulmonary Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04887298
Recruitment Status : Recruiting
First Posted : May 14, 2021
Last Update Posted : February 10, 2023
Sponsor:
Information provided by (Responsible Party):
Moleculin Biotech, Inc.

Study Description
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Brief Summary:
This is a multi-center, open-label, single-arm study that in Phase 1b will determine the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) and safety of L-Annamycin and in Phase 2 will explore the efficacy of L- Annamycin as a single agent for the treatment of subjects with STS with lung metastases for which chemotherapy is considered appropriate.

Condition or disease Intervention/treatment Phase
Sarcoma,Soft Tissue Pulmonary Metastasis Drug: Liposomal Annamycin (L-Annamycin) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1B/2 Study Of Liposomal Annamycin (L-Annamycin) In Subjects With Previously Treated Soft-Tissue Sarcomas With Pulmonary Metastases
Actual Study Start Date : June 5, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Liposomal Annamycin (L-Annamycin) Drug: Liposomal Annamycin (L-Annamycin)
2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: 21 days ]
    Number of patients with a dose limiting toxicity (DLT) at each dose evaluated


Secondary Outcome Measures :
  1. Efficacy of L-Annamycin [ Time Frame: At the end of every other treatment cycle ( each cycle is 21 days) ]
    Determine preliminary efficacy of L-Annamycin as per revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)

  2. Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin [ Time Frame: Cycle 1 Day 1 ( each cycle is 21 days) ]
    Determine pharmacokinetics of L-Annamycin and its metabolite, annamycinol as measured by AUC


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The subject has a pathologically confirmed diagnosis of STS.
  2. The subject must have radiographically measurable disease in the lung that can be assessed using RECIST v.1.1 (defined as the presence of at least one lesion on MRI or CT scan that can be accurately measured with the longest diameter in at least one dimension of ≥10 mm). Subjects with extra-pulmonary disease are eligible.
  3. The subject has documented lung metastases that are considerable eligible for chemotherapy and not eligible for potentially curative surgical resection of pulmonary-only metastatic disease.
  4. The subject had prior therapy for their disease and has shown progression of disease prior to study entry. If the subject received prior anthracycline therapy, they must have received a cumulative dose of ≤ 450 mg/m2.
  5. The subject has an estimated life expectancy of greater than 3 months.
  6. The subject has an ECOG performance status ≤2.
  7. The subject is ≥18 years old at the time of signing informed consent.
  8. At least 2 weeks must have passed following treatment for subject's disease with chemotherapy, investigational therapy, targeted agents, biological agents, immune modulators, or radiotherapy.
  9. Any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than 4 weeks after completing therapy (except alopecia and polyneuropathy).

  10. The subject must have the following adequate laboratory results within 72 hours of starting protocol therapy:

    1. Absolute neutrophil count ≥ 1500/mL
    2. Platelet count ≥100,000/mL
    3. Hemoglobin ≥ 8.0 g/dL

    4. Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance.

      CrCl (male) = ([140-age] x weight in kg) / (serum creatinine x 72)

      CrCl (female) = ([140-age] x weight in kg) / (serum creatinine x 72) x .85

    5. Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome)
    6. Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and/or alanine aminotransferase (serum glutamic pyruvic transaminase) ≤ 2.5 × ULN (≤ 5 x ULN in subjects with liver metastases)
  11. The subject is able to understand and sign the informed consent document, can communicate with the Investigator, and can understand and comply with the requirements of the protocol.

  12. All subjects must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists.

    1. Sexually active, fertile women must agree to use 2 effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug
    2. Sexually active men and their sexual partners must agree to use effective contraceptive methods from the time of informed consent until at least 6 months after discontinuing study drug

Exclusion Criteria:

  1. The subject has any uncontrolled intercurrent illness that, in the opinion of the Investigator, would place the subject at unacceptable risk to participate in the study. Examples include, but are not limited to:

    1. Ongoing or active infection
    2. Known positive status for human immunodeficiency virus (HIV) or active hepatitis B or C
    3. Cirrhosis
    4. Psychiatric illness/social situations that would limit compliance with study requirements

  2. The subject has any of the following cardiotoxicities:

    1. Left ventricular ejection fraction (LVEF) <50%
    2. Valvular heart disease
    3. Severe hypertension not controlled by medical therapy
    4. New York Heart Association classification of 3 or 4 (Appendix B)
    5. Recent (≤ 6 months) myocardial infarction
    6. Unstable angina
    7. Symptomatic congestive heart failure
    8. Baseline QT/QTc interval >480 msec
    9. History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
    10. Use of concomitant medications that significantly prolong the QT/QTc interval
  3. The subject is pregnant (must have negative serum or urine pregnancy test) or lactating.
  4. The subject has a known allergy to study drug, L-Annamycin, or excipients.
  5. The subject is required to use moderate or strong inhibitors and inducers of Cytochrome P450 family enzymes CYP3A and CYP2B and transporters that cannot be held 3 days before treatment and on the day of treatment (Appendix E).
  6. The subject is unable to comply with the safety monitoring requirements.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887298


Contacts
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Contact: Robert Shepard, MD (713) 300-5160 rshepard@moleculin.com
Contact: Cynthia Abbate (713) 300-5160 cabbate@moleculin.com

Locations
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United States, California
Sarcoma Oncology Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria Chua-Alcala    310-552-9999    vchua@sarcomaoncology.com   
Principal Investigator: Sant Chawla, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Michele Landeau       landeaum@wustl.edu   
Principal Investigator: Brian Van Tine, MD/PhD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Pooja Shah       pss123@cinj.rutgers.edu   
Principal Investigator: Sarah Weiss, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Danielle Dever    614-685-9353    Danielle.dever@osumc.edu   
Principal Investigator: David Liebner, M.D.         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Min Du    713-792-3626    mdu@mdanderson.org   
Principal Investigator: Maria A Zarzour, MD         
Sponsors and Collaborators
Moleculin Biotech, Inc.
Investigators
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Study Director: Robert Shepard, MD Moleculin Biotech, Inc.
More Information
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Responsible Party: Moleculin Biotech, Inc.
ClinicalTrials.gov Identifier: NCT04887298    
Other Study ID Numbers: MB-107
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: February 10, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Lung Neoplasms
Lung Diseases
Sarcoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Annamycin
Antibiotics, Antineoplastic
Antineoplastic Agents