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Sarcoma,Soft TissuePhase 1/2NCT04887298

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

A Phase 1/2 study testing Liposomal Annamycin (L-Annamycin) in people with Sarcoma,Soft Tissue and Pulmonary Metastasis, run by Moleculin Biotech, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoma,Soft Tissue, Pulmonary Metastasis
What is being tested?
Liposomal Annamycin (L-Annamycin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
5 sitesUnited States
Study dates
5 Jun 2021to 6 Aug 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has a pathologically confirmed diagnosis of STS.
  • 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.
  • 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.
  • 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.
  • The subject has an estimated life expectancy of greater than 3 months.
  • The subject has an ECOG performance status ≤2.
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  • The subject is ≥18 years old at the time of signing informed consent.
  • 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.
  • Any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than 4 weeks after completing therapy (except alopecia and polyneuropathy).
  • The subject must have the following adequate laboratory results within 72 hours of starting protocol therapy:
  • Absolute neutrophil count ≥ 1500/mL
  • Platelet count ≥100,000/mL
  • Hemoglobin ≥ 8.0 g/dL
  • 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
  • Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome)
  • 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)
  • 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.
  • All subjects must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists.
  • 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
  • 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

Who cannot join

  • 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:
  • Ongoing or active infection
  • Known positive status for human immunodeficiency virus (HIV) or active hepatitis B or C
  • Cirrhosis
  • Psychiatric illness/social situations that would limit compliance with study requirements
  • The subject has any of the following cardiotoxicities:
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  • Left ventricular ejection fraction (LVEF) <50%
  • Valvular heart disease
  • Severe hypertension not controlled by medical therapy
  • New York Heart Association classification of 3 or 4 (Appendix B)
  • Recent (≤ 6 months) myocardial infarction
  • Unstable angina
  • Symptomatic congestive heart failure
  • Baseline QT/QTc interval >480 msec
  • History of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • Use of concomitant medications that significantly prolong the QT/QTc interval
  • The subject is pregnant (must have negative serum or urine pregnancy test) or lactating.
  • The subject has a known allergy to study drug, L-Annamycin, or excipients.
  • 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).
  • The subject is unable to comply with the safety monitoring requirements.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Ohio State University

    Columbus, Ohio, 43210

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Phase 1B/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects with Previously Treated Soft-Tissue Sarcomas with Pulmonary Metastases

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.

Being tested
Liposomal Annamycin (L-Annamycin)
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal Annamycin (L-Annamycin)Drug

    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)

Study groups in NCT04887298
Study groupRoleWhat they receive
Liposomal Annamycin (L-Annamycin)ExperimentalNot described
Receives: Drug: Liposomal Annamycin (L-Annamycin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity

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

    Measured: 21 days

Secondary outcomes (2)

  1. Efficacy of L-Annamycin

    Determine preliminary efficacy of L-Annamycin as per revised Response Evaluation Criteria in Solid Tumors (RECIST) guidelines (version 1.1)

    Measured: At the end of every other treatment cycle ( each cycle is 21 days)

  2. Area Under the Plasma Concentration Versus Time Curve (AUC) of L-Annamycin

    Determine pharmacokinetics of L-Annamycin and its metabolite, annamycinol as measured by AUC

    Measured: Cycle 1 Day 1 ( each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start5 Jun 2021
  3. Primary completion29 Sep 2022
  4. Study completion6 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887298
Sponsor's protocol ID
MB-107
Status last verified
Oct 2024
First submitted
4 May 2021
Last updated
24 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Liposomal Annamycin (L-Annamycin) in people with Sarcoma,Soft Tissue and Pulmonary Metastasis, run by Moleculin Biotech, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.

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