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New pill shows promise in slowing rare Cancer's growth

NCT ID NCT07032285

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental oral drug called cirtuvivint for people with advanced soft-tissue sarcoma that has not responded to prior treatment. About 25 participants in Spain will take the drug to see if it can stop or slow cancer growth for at least 3 months. The drug targets enzymes involved in cell division and is still under investigation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow up. Informed consent must be obtained prior to the start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g., imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol. 2. Age: 16-70 years. 3. Patients with a diagnosis of advanced unresectable soft-tissue sarcoma and not candidates for surgical rescue including only the following subtypes: solitary fibrous tumor (SFT), synovial sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma (EMC), alveolar soft part sarcoma and myxoid liposarcoma. Additionally, the Hospital Universitario Fundación Jiménez Díaz will include 2 desmoid tumor patients as proof of concept outside the total n. 4. Metastatic/locally advanced with recent progression (\<6 months). 5. Patients should have received at least anthracyclines previously unless not indicated (SFT). 6. Measurable disease according to RECIST 1.1 criteria. 7. Patients must be willing to provide consent for the provision of mandatory biological samples for central pathology review (tumor sample from the three months prior to the start of treatment if the patient has not received any systemic therapy) and translational study (tumor blocks and blood). 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 9. Adequate hepatic, renal, cardiac, and hematologic function. 10. Laboratory tests as follows: * Absolute neutrophil count ≥1,500/mm³ * Platelet count ≥100,000/mm³ * Bilirubin ≤1.5 mg/dL * AST and ALT ≤2.5 times upper limit of normal * Creatinine ≤1.5 mg/dL 11. Left ventricular ejection fraction ≥50% by echocardiogram or MUGA scan. 12. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women/men of reproductive potential must have agreed to use a highly effective contraceptive method. 13. Subjects must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation. Exclusion criteria: Patients meeting any of the following exclusion criteria are not eligible to be enrolled in this study: 1. Previous treatment with CLK inhibitors. 2. Patients who have received any other anti-cancer therapy or investigational product in the last 28 days prior to enrollment. 3. Four or more systemic therapy lines for advanced disease. 4. Sarcoma subtypes other than the specified in the inclusion criteria. 5. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 3 years prior to enrollment. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed. 6. Any concurrent medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures. 7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable. 8. Pregnant or breastfeeding females. 9. Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Du Bois (33) or Mosteller (34) method. 10. Life expectancy of less than 3 months. 11. Major surgery within 28 days prior to C1D1. 12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment. 13. Inability or unwillingness to take supportive medications such as anti-nausea and anti anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia/cachexia (palliative care). 14. Any active, serious psychiatric, medical, or other conditions/situations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Subjects with a corrected QT interval (QTc) using Fridericia's formula (QTcF) \> CTCAE v5.0 Grade 1 (\>480 msec) based on the mean of triplicate evaluation at screening. In subjects with ventricular paced rhythm, a 50 msec subtraction should be applied to the QTc to calculate the QTcF, potential exceptions for subjects with pacemakers should be discussed with the Medical Monitor. 16. Subjects with clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), ventricular fibrillation (VF), second or third degree heart block. 17. Subjects with myocardial infarction (MI) within 1 year, Class II-IV congestive heart failure (CHF) per New York Heart Association (NYHA) classification, or clinically significant coronary artery disease (CAD). 18. Subjects currently using or anticipating the need for food or drugs known to strongly inhibit or induce CYP3A4, such as ketoconazole, itraconazole, erythromycin, or rifampin, within 10 days prior to first dose of study medication. 19. Subjects with retinal abnormalities, specifically diabetic retinopathy, macular degeneration, other forms of retinal degenerative disease, or other retinal findings that may place the subject at risk (the latter should be discussed with the Medical Monitor). 20. Subjects with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. 21. Patient is unwilling to participate in the translational study (not providing mandatory written consent for tumor and blood samples).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Medical Oncology Department, HU Fundación Jimenez Diaz

    RECRUITING

    Madrid, Madrid, 28040, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.