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New treatment option for Soft Tissue Sarcoma (STS)
Official title Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
ClinicalTrials.gov ID: NCT07032285
What this study is testing
What is Cirtuvivint?
Cirtuvivint is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for soft tissue sarcoma (sts).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is a Phase 2 clinical trial of the drug cirtuvivint as a second-line treatment for advanced soft tissue sarcomas. The study is being conducted in Spain and is expected to enroll approximately 25 patients in total.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
You may be able to join if
- Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and...
- Age: 16-70 years.
- Patients with a diagnosis of advanced unresectable soft-tissue sarcoma and not candidates for surgical rescue including only the following subtypes...
- Metastatic/locally advanced with recent progression (\<6 months).
- Patients should have received at least anthracyclines previously unless not indicated (SFT).
You likely can't join if
- Patients meeting any of the following exclusion criteria are not eligible to be enrolled in this study:
- Previous treatment with CLK inhibitors.
- Patients who have received any other anti-cancer therapy or investigational product in the last 28 days prior to enrollment.
- Four or more systemic therapy lines for advanced disease.
- Sarcoma subtypes other than the specified in the inclusion criteria.
- Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical...
See the full eligibility criteria
Who can join
- 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...
- Age: 16-70 years.
- 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...
- Metastatic/locally advanced with recent progression (\<6 months).
- Patients should have received at least anthracyclines previously unless not indicated (SFT).
- Measurable disease according to RECIST 1.1 criteria.
- 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...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Adequate hepatic, renal, cardiac, and hematologic function.
- 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
- Left ventricular ejection fraction ≥50% by echocardiogram or MUGA scan.
- 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...
- people must be willing to avoid extensive sun exposure, phototherapy, and use of a tanning salon during trial participation.
What rules you out
- Patients meeting any of the following exclusion criteria are not eligible to be enrolled in this study:
- Previous treatment with CLK inhibitors.
- Patients who have received any other anti-cancer therapy or investigational product in the last 28 days prior to enrollment.
- Four or more systemic therapy lines for advanced disease.
- Sarcoma subtypes other than the specified in the inclusion criteria.
- 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...
- 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.
- 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...
- Pregnant or breastfeeding females.
- Body surface area (BSA) \<1.4 m2 at baseline, calculated by the Du Bois (33) or Mosteller (34) method.
- Life expectancy of less than 3 months.
- Major surgery within 28 days prior to C1D1.
- Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.
- 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).
- 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.
- people 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 people with ventricular paced rhythm, a 50 msec...
- people with clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), ventricular fibrillation (VF), second or third degree heart block.
- people 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).
- people 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...
- people 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...
- people with known active human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Patient is unwilling to participate in the translational study (not providing mandatory written consent for tumor and blood samples).
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
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, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.