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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitario De Canarias	La Laguna	Spain
Hcsobqyx Dc Ln Sqhoc Crot I Sgam Pwb	Barcelona	Spain
Hbxqrnsu Vpjg drlwyghu	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.01.2025

Trial locations

Investigated drugs:

CIRTUVIVINT

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.

Investigated diseases:

Soft tissue sarcoma

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 ID:

2024-511987-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?