Soft Tissue Sarcoma (STS)
Conditions
Brief summary
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. The primary objective of this Phase 2 study is to evaluate the efficacy of treatment with cirtuvivint. Cirtuvivint is an anti-cancer medication developed by the U.S. company Biosplice Therapeutics, Inc. This drug is an inhibitor of the enzymes CLK1-4 and DYRK1-4 (molecules involved in the cell cycle) and is administered as oral tablets. This product is still under investigation and has not yet been approved in Europe.
Interventions
DRUGCirtuvivint
Cirtuvivint (SM08502) will be administered orally at 80 mg/day, 5 days on/2 days off. Cirtuvivint is supplied as tablets containing 10 mg or 50 mg of the active pharmaceutical ingredient (API). Cirtuvivint is taken with water once a day (on dosing days) at the same time every day. Doses will be taken without food (foo restriciton 1 hour before treatment and 2 hours afterdosing). Doses delayed by 12 hours will be considered missed and should not be taken. If vomiting occurs,the dose must not be retaken. Cirtuvivint is dosed in 28-day continuous cycles (28 days of treatment will beconsidered as one cycle) Treatment will continue until disease progression, unacceptable toxicity or investigator/patient decision
Sponsors
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
TenaRx, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the progression-free survival rate (PFSR) at 3 months. | 3 months | PFSR-3m (according to central radiology assessment): Efficacy measured by the PFSR at 3 months, which is defined as the percentage of patients who did not experience radiological progression according to RECIST v1.1 or death due to any cause since the date of treatment initiation until month 3 after date of treatment initiation. |
Countries
Spain
Contacts
CONTACTNadia Hindi, MD
Outcome results
None listed