Actively Recruiting
Multicenter, Open-Label Phase II Trial of Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Led by Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas · Updated on 2026-04-06
25
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
A
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Lead Sponsor
T
TenaRx, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the drug cirtuvivint as a second-line treatment for advanced soft tissue sarcomas in this Phase 2 clinical trial. The study aims to assess how well cirtuvivint works in patients with selected subtypes of advanced unresectable soft-tissue sarcomas who have progressed recently and are not candidates for surgery. This trial is conducted in Spain and plans to enroll about 25 patients. Participants will receive cirtuvivint orally at a dose of 80 mg per day, taken 5 days on and 2 days off, in 28-day cycles. The drug is supplied as tablets and taken once daily with water at the same time each day, without food at least 1 hour before and 2 hours after dosing. Treatment continues until disease progression, unacceptable side effects, or patient or investigator decision. Doses missed due to delay or vomiting are not repeated. During the study, participants will be monitored for disease progression and side effects, with evaluations including imaging and laboratory tests to confirm measurable disease and organ function. The main outcome measured is progression-free survival rate at 3 months. Patients will also provide tumor and blood samples for research. Safety and treatment adherence will be tracked throughout the trial, which lasts as long as treatment continues under study guidelines.
CONDITIONS
Brief Title
Cirtuvivint in Selected Advanced Soft-Tissue Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 to 70 years
- Diagnosis of advanced unresectable soft-tissue sarcoma of specific subtypes including solitary fibrous tumor, synovial sarcoma, clear cell sarcoma, extraskeletal myxoid chondrosarcoma, alveolar soft part sarcoma, and myxoid liposarcoma
- Recent disease progression within the last 6 months
- Prior treatment with anthracyclines unless not indicated
- Measurable disease according to RECIST 1.1 criteria
- Willingness to provide informed consent and comply with treatment and follow-up
- ECOG Performance Status 0-1
- Adequate liver, kidney, heart, and blood function as defined by lab tests
- Negative pregnancy test and agreement to use effective contraception for females of childbearing potential
- Willingness to avoid extensive sun exposure and tanning during the trial
- Consent to provide mandatory biological samples for pathology and translational studies
You will not qualify if you...
- Previous treatment with CLK inhibitors
- Receipt of other anti-cancer therapy or investigational product within 28 days before enrollment
- Four or more prior systemic therapy lines for advanced disease
- Sarcoma subtypes not specified in inclusion criteria
- Prior malignancy requiring treatment or recurrence within 3 years (except certain treated cancers)
- Any concurrent medical condition likely to interfere with study procedures
- Uncontrolled active infection requiring intravenous antibiotics, antivirals, or antifungals within 1 week prior to treatment
- Pregnant or breastfeeding females
- Body surface area less than 1.4 m2
- Life expectancy under 3 months
- Major surgery within 28 days prior to treatment
- Active gastrointestinal dysfunction interfering with swallowing or absorption of tablets
- Inability or unwillingness to take supportive medications as recommended
- Serious psychiatric, medical, or other conditions interfering with treatment or consent
- Abnormal heart rhythm or significant heart disease
- Use or anticipated need for drugs strongly affecting CYP3A4 within 10 days before first dose
- Retinal abnormalities that increase risk
- Known active HIV, hepatitis B, or hepatitis C infection
- Unwillingness to participate in mandatory tumor and blood sample collection for translational study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation.
Participants take the study drug Cirtuvivint orally in 28-day cycles, 5 days on treatment followed by 2 days off, continuing until disease progression, unacceptable side effects, or decision to stop.
Visits occur regularly during each treatment cycle to monitor safety and response
Trial Site Locations
Total: 1 location
1
Medical Oncology Department, HU Fundación Jimenez Diaz
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
N
Nadia Hindi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here