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Clinical Trials in Spain / NCT06114004
Recruiting Phase 2

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

NCT06114004 · tracked via the Priya Life Science Spain tracker
Sponsor
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Phase
Phase 2
Started
2023-09-28
Last updated
2025-06-25

Condition(s) studied

Sarcoma,Soft Tissue

Investigational drug(s) / intervention(s)

Selinexor 20 MG →Gemcitabine →

Selinexor 20 MG: After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor

Gemcitabine: Gemcitabine will be given at the dose 1200 mg/m2 (10 mg/m2/min) days 1 and 8 every 21 days.

Study summary

Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.

Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 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 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: 18-80 years. 3. Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products. 4. Metastatic/advanced disease in progression in the last 6 months. 5. Patients have previously received at least one previous line of systemic therapy. 6. Measurable disease according to RECIST 1.1 criteria. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 8. Adequate hepatic, renal, cardiac, and hematologic function. 9. 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 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan. 11\. 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 an effective contraceptive method. Exclusion Criteria: 1. Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic). 2. Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment. 3. 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 5 years prior to randomization. Cancer treated with curative intent for \>5 years previously and without evidence of recurrence will be allowed. 4. Prior selinexor or another XPO1 inhibitor treatment. 5. Administration of a previous gemcitabine-containing treatment. 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(25) or Mosteller(26) method. 10. Life expectancy of less than 3 months. 11. Major surgery within 4 weeks 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. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible) 15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Hospital Universitario de Canarias Santa Cruz de Tenerife Canary Islands Not Yet Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Spain Recruiting
Hospital Universitario Vall d'Hebron Barcelona Spain Recruiting
Hospital Universitario de Donostia Donostia / San Sebastian Spain Not Yet Recruiting
Hospital General Universitario Gregorio Marañón Madrid Spain Not Yet Recruiting
Hospital Clínico San Carlos Madrid Spain Recruiting
Hospital Universitario Fundación Jiménez Díaz Madrid Spain Recruiting
Hospital Universitario La Paz Madrid Spain Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain Not Yet Recruiting
Hospital Clinico Universitario Valencia Valencia Spain Not Yet Recruiting
Hospital Universitario Miguel Servet Zaragoza Spain Recruiting

More Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06114004 on ClinicalTrials.gov ↗ ← All trials in Spain