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Soft Tissue SarcomaPhase 1/2ANNA-SARCNCT05518526

Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases

A Phase 1/2 study testing Liposomal Annamycin (L-Annamycin) in people with Soft Tissue Sarcoma and Pulmonary Metastasis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multi-centre, open-label, single-arm, 3+3 Phase 1b/ and Phase II. Phase 1b is aimed to determine the maximum-tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) based on safety reporting. The RP2D is a multifactorial endpoint that considers toxicity as well as additional determinants (e.g. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma, 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
64 participants
Where
1 sitePoland
Study dates
23 Aug 2022to Aug 2025
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 is ≥18 years old at the time of signing informed consent.
  • The subject has an ECOG performance status ≤2 with an estimated life expectancy of greater than three months.
  • The subject has a pathologically confirmed diagnosis of STS (including the following pathological subtypes: liposarcoma, leiomyosarcoma, synovial sarcoma, angiosarcoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, malignant peripheral nerve sheath tumour, malignant solitary fibrous tumour, and pleomorphic RMS), and documented lung metastases that are considered eligible for chemotherapy and not eligible for potentially curative surgical resection.
  • The subject must have measurable disease in the lung, defined as, at a minimum, one lesion that can be accurately measured in at least one dimension of >10 mm. Subjects with the extra-pulmonary disease are eligible.
  • The subject had prior anthracycline therapy (cumulative dose of ≤450 mg/m2) for their disease and has shown the progression of the disease before study entry - for phase II trial maximum of three previous lines of therapy (adjuvant/neoadjuvant regimen is counted as one line of systemic treatment)
  • At least two weeks must have passed following treatment for their disease with chemotherapy, investigational therapy, targeted agents, biological agents, immune modulators, and any toxicities must have resolved to ≤ grade 1 or previous baseline levels no more than four weeks after completing therapy (except alopecia and polyneuropathy).
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  • The subject must have adequate laboratory results, including the following:
  • Absolute neutrophil count ≥ 1500/mL and platelets ≥100,000/mL
  • Hemoglobin ≥8.0 g/dL
  • Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in milliliters per minute= [140-age] x body weight [kg]/72 x plasma creatinine [mg/dL]; multiplied by 0.85 for women. By using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 mL/minute)
  • Bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 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.
  • Vaccinated with a live vaccine within 28 days prior to the first dose of the study drug. COVID-19 vaccination with mRNA or replication incompetent viral vector vaccines and annual inactivated influenza vaccines are permitted.
  • All subjects (men and women) agree to practise effective contraception during the entire study period and after discontinuing the study drug unless documentation of infertility exists.
  • Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least six months after discontinuing the study drug.
  • Sexually active men and their sexual partners must use effective contraceptive methods from the time of informed consent until at least six months after discontinuing the study drug.

Who cannot join

  • The subject has any condition that, in the opinion of the Investigator, places the subject at unacceptable risk if they were to participate in the study.
  • Metastases to the central nervous system
  • The subject has left ventricular ejection fraction (LVEF) <50%, valvular heart disease, or severe hypertension not controlled by medical therapy. Cardiac subjects with a New York Heart Association classification of 3 or 4 will be excluded, as will those with recent (≤ 6 months) myocardial infarction, unstable angina, or symptomatic congestive heart failure. The subject has a baseline QT/QTc interval >480 msec, a history of additional risk factors for torsade des pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) and use of concomitant medications that significantly prolong the QT/QTc interval.
  • The subject has clinically relevant serious comorbid medical conditions including, but not limited to active infection, known positive status for human immunodeficiency virus and/or active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements.
  • The subject is pregnant, lactating, or not using adequate contraception.
  • The subject has a known allergy to study drug or excipients.
  • The subject is required to use moderate or strong inhibitors and inducers of cytochrome P450 (CYP) family enzymes CYP3A and CYP2B and transporters that cannot be held three days before treatment and on the day of treatment.

Trial locations and contacts

1 site in 1 country.

Piotr Rutkowski, MD PhD Professor contact

+48225462184

piotr.rutkowski@pib-nio.pl

Poland1 site, 1 recruiting

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, Mazovian, 02-781

    Piotr Rutkowski, MD PhD Professor, +48225462184, piotr.rutkowski@pib-nio.pl

    Recruiting

Other trials in Poland

About this study

Official title: Phase 1b/2 Study of Liposomal Annamycin (L-Annamycin) in Subjects With Previously Treated Soft-Tissue Sarcomas (STS) With Pulmonary Metastases (ANNA-SARC)

This study is a multi-centre, open-label, single-arm, 3+3 Phase 1b/ and Phase II. Phase 1b is aimed to determine the maximum-tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) based on safety reporting. The RP2D is a multifactorial endpoint that considers toxicity as well as additional determinants (e.g. efficacy, pharmacodynamics) to define the optimal Phase 2 dose. Phase 2 will explore the efficacy of L-Annamycin at RP2D for treating soft tissue sarcomas (STS) subjects with lung metastases, for which chemotherapy is considered appropriate.

Read the detailed description

The project aims to conduct a Phase 1b/2 clinical trial using liposomal Annamycin (L-Annamycin) in subjects diagnosed with soft tissue sarcoma (STS) in the stage of unresectable pulmonary dissemination after the failure of at least one line of prior systemic treatment.

The most common localisation of metastatic lesions in STS is the lungs (refer to this as a "sanctuary site" for STS). Furthermore, although the most common dosing regimen for other anthracyclines (typically, doxorubicin) in the treatment of STS has historically been once every three weeks, preclinical testing of L-Annamycin suggests that weekly dosing of L-Annamycin may be more beneficial, as well as it seems to be both safer and more effective than alternative schedules.

Therefore, this Phase Ib/II clinical trial will test the hypothesis that L-Annamycin administration in monotherapy in the weekly schedule (D1, D8, D15 in 28-day cycles) is safe and has the pharmacodynamic (PD) potential to restore and enhance tumour responses in anthracycline-pre-treated subjects with advanced and/or metastatic STS until disease progression, unacceptable toxicities, or subject consent withdrawal.

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

    Study drug consists of L-Annamycin as a lyophilised powder in 50-mL single-use vials containing 45 mg of L-Annamycin must be reconstituted with 45 mL of 0.9% sodium chloride injection between 34 to 42℃, USP, and then diluted 1:1 with 0.9% sodium chloride injection between 34 to 42℃ in non-polyvinyl chloride IV bags before intravenous infusion. The dose of L-Annamycin will be intravenously applied during 2 hours infusion on D1, D8, and D15 of each 28-day cycle (up to Cycle 6th).

Study groups in NCT05518526
Study groupRoleWhat they receive
L-AnnamycinExperimentalNot 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. Phase Ib: Recommended Phase 2 Dose (RP2D).

    Measured: up to 24 weeks

  2. Phase II: 3-month Progression-Free Survival (PFS).

    Measured: 3 months

Secondary outcomes (1)

  1. Phase Ib/II: Overall response rate (ORR): complete response (CR) and partial response (PR)

    Measured: 3 months

Timeline

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

  1. First posted26 Aug 2022
  2. Study start23 Aug 2022
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

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
Single group
Masking
None (open label)
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05518526
Sponsor's protocol ID
NIO-0002
Acronym
ANNA-SARC
Status last verified
Aug 2022
First submitted
24 Aug 2022
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Liposomal Annamycin (L-Annamycin) in people with Soft Tissue Sarcoma and Pulmonary Metastasis, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

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 17 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Results are not available in the source record.

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

Contact Piotr Rutkowski, MD PhD Professor (+48225462184, piotr.rutkowski@pib-nio.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Recommended Phase 2 Dose (RP2D). (time frame: up to 24 weeks). The study lists 2 primary outcomes in all. 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 NCT05518526.

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 26 Aug 2022.

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