Ended Phase I and Phase II (Integrated)- Other METASTATIC SOFT-TISSUE SARCOMAS AFTER FAILURE ON AT LEAST ONE SYSTEMIC THERAPY

Phase 1b/2 study of liposomal annamycin (l-annamycin) in patients with previously treated metastatic soft-tissue sarcomas (ANNA-SARC)

EU CTIS ID: 2024-517678-12-00

What this study is testing

Phase Ib: To establish the safety and tolerability of weekly dosed L-Annamycin in monotherapy in subjects with STS with metastases. Phase II: To determine the efficacy of L-Annamycin in subjects with STS with metastases.

  • Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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 metastases that are considered eligible for chemotherapy and not eligible for potentially curative surgical resection.
  • The subject must have measurable disease, defined as, at a minimum, one lesion that can be accurately measured in at least one dimension of >10 mm. Subjects with additional sites of disease are eligible.
  • The subject had prior anthracycline therapy (cumulative dose of ≤5000 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).

You likely can't join if

  • 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.
See the full eligibility criteria
Who can 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 metastases that are considered eligible for chemotherapy and not eligible for potentially curative surgical resection.
  • The subject must have measurable disease, defined as, at a minimum, one lesion that can be accurately measured in at least one dimension of >10 mm. Subjects with additional sites of disease are eligible.
  • The subject had prior anthracycline therapy (cumulative dose of ≤5000 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).
  • The subject must have adequate laboratory results, including the following: a. Absolute neutrophil count ≥ 1500/mL and platelets ≥100,000/mL b. Hemoglobin ≥8.0 g/dL c. 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) d. Bilirubin ≤1.5 x ULN (unless due to Gilbert’s syndrome) e. 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.
  • 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. a. 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. b. 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.
What rules you out
  • 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.
  • 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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.