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Study of Cirtuvivint for Patients with Advanced Soft-Tissue Sarcomas as a Second-Line Treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a group of cancers known as advanced soft-tissue sarcomas. These are rare types of cancer that develop in the soft tissues of the body, such as muscles, fat, and blood vessels. The study is specifically looking at certain subtypes of these sarcomas, including leiomyosarcoma, solitary fibrous tumor, synovial sarcoma, and myxoid liposarcoma. The treatment being tested in this trial is a medication called Cirtuvivint, which is taken in the form of a tablet. Cirtuvivint is being evaluated as a second-line therapy, meaning it is used after the initial treatment has not been successful.

The purpose of this study is to assess how well Cirtuvivint works in preventing the cancer from getting worse over a period of three months. Participants in the trial will receive Cirtuvivint and will be monitored to see how their cancer responds to the treatment. The study will also look at the safety of the medication and how well patients tolerate it. This will involve regular check-ups and tests to monitor any side effects and overall health. The trial aims to provide valuable information on the effectiveness and safety of Cirtuvivint for patients with these specific types of sarcomas.

Throughout the study, participants will be asked to avoid certain activities, such as extensive sun exposure and the use of tanning salons, to ensure the best possible results. The trial will last for a period of time, with regular follow-ups to track the progress of the treatment. By participating in this study, researchers hope to gain a better understanding of how Cirtuvivint can be used to help manage advanced soft-tissue sarcomas and improve the quality of life for patients affected by these cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, the patient will be required to provide written informed consent. This consent is necessary before any study-specific procedures can begin.

    The patient must agree to comply with the treatment plan and follow-up schedule.

  2. Step 2

    Screening

    The patient will undergo various laboratory tests to ensure eligibility. These tests include checking blood cell counts, liver function, and kidney function.

    An echocardiogram or MUGA scan will be performed to assess heart function.

    For females of childbearing potential, a pregnancy test will be conducted within 72 hours prior to enrollment.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with Cirtuvivint, administered orally in tablet form.

    The dosage and frequency of administration will be determined by the study protocol.

  4. Step 4

    Treatment phase

    The patient will continue taking Cirtuvivint as prescribed.

    Regular assessments will be conducted to monitor the patient's response to the treatment and any side effects.

  5. Step 5

    Follow-up assessments

    The patient's progression-free survival rate will be evaluated at 3 months.

    Safety and tolerability will be assessed through physical examinations and laboratory tests.

    Quality of life will be measured using a specific questionnaire.

  6. Step 6

    End of trial

    The trial is estimated to conclude by July 2027.

    Final assessments will be conducted to evaluate the overall response rate and survival outcomes.

Who can join the trial?

17 criteria

  • Patients must provide written informed consent before any study-specific procedures and agree to follow the treatment and follow-up plan.
  • Laboratory tests must show:
    • Absolute neutrophil count of at least 1,500 cells per cubic millimeter (a type of white blood cell important for fighting infections).
    • Platelet count of at least 100,000 per cubic millimeter (cells that help with blood clotting).
    • Bilirubin level of 1.5 milligrams per deciliter or less (a substance made by the liver).
    • AST and ALT levels no more than 2.5 times the upper limit of normal (enzymes that show liver function).
    • Creatinine level of 1.5 milligrams per deciliter or less (a waste product filtered by the kidneys).
    • Left ventricular ejection fraction of 50% or more, measured by an echocardiogram or MUGA scan (tests that check heart function).
    • Females of childbearing potential must have a negative pregnancy test within 72 hours before joining the study and agree to use birth control during treatment and for 3 months after. Patients must not be pregnant or nursing when entering the study. Both women and men of reproductive potential must agree to use a highly effective contraceptive method.
    • Subjects must agree to avoid extensive sun exposure, phototherapy, and tanning salons during the trial.
    • Age must be between 16 and 70 years.
    • Patients must have a diagnosis of advanced soft-tissue sarcoma that cannot be surgically removed, including specific subtypes: leiomyosarcoma, solitary fibrous tumor (SFT), synovial sarcoma, and myxoid liposarcoma.
    • The disease must be metastatic (spread to other parts of the body) or locally advanced with recent progression within the last 6 months.
    • Patients should have previously received anthracyclines (a type of chemotherapy) unless not suitable for SFT.
    • The disease must be measurable according to RECIST 1.1 criteria (a standard way to measure tumor size and response to treatment).
    • Mandatory paraffin-embedded tumor samples must be provided for central review and research purposes before treatment.
    • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, indicating they are fully active or have some symptoms but do not require bed rest.
    • Patients must have adequate liver, kidney, heart, and blood function.

Who cannot join the trial?

5 criteria

  • Patients with medical conditions other than Selected Advanced Soft-Tissue Sarcomas cannot participate. This means the study is only for those with specific types of soft-tissue cancer.
  • Patients who are not within the specified age ranges cannot participate. The study is for certain age groups, so if you are outside these ages, you cannot join.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people who fit into certain categories or groups.
  • Patients who are not male or female cannot participate. The study is open to both men and women.
  • Patients who are not considered part of a vulnerable population cannot participate. This means the study includes people who might need extra care or protection.
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Investigated drugs

Cirtuvivint is being studied as a second-line treatment for advanced soft-tissue sarcomas. This means it is used after the initial treatment has not been successful. The goal of using Cirtuvivint in this trial is to see if it can help stop the cancer from getting worse over a period of three months.

What is already known about the treatment

Cirtuvivint – Cirtuvivint is administered orally in the form of tablets. It is currently being studied in clinical trials as a second-line treatment for selected advanced soft-tissue sarcomas. The medication is not yet widely recognized in medical literature as it is still under investigation. Its main therapeutic indication is to improve progression-free survival in patients with these specific types of sarcomas. Cirtuvivint works by inhibiting certain proteins involved in cell growth, which may help slow down or stop the progression of cancer. It is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

Selected Advanced Soft-Tissue Sarcomas – These are a group of cancers that originate in the soft tissues of the body, such as muscles, fat, nerves, and blood vessels. They are considered advanced when they have spread beyond their original location or are not responding to standard treatments. The progression of these sarcomas can vary, but they typically grow and spread to other parts of the body over time. Symptoms may include a noticeable lump or swelling, pain, or limited movement in the affected area. The rate of progression and specific symptoms can differ depending on the type and location of the sarcoma.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511987-10-00Estimated enrolment28 patientsSponsorAsociacion Europea Y Latinoamericana SELNET Para La Investigacion En Sarcomas

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).