RecruitingPhase 2NCT06114004

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

Phase I/II Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas


Sponsor

Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

Enrollment

88 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of selinexor (a targeted cancer drug) and gemcitabine (a chemotherapy) in patients with advanced soft-tissue sarcoma — cancers that develop in fat, muscle, tendons, or other soft tissues. The goal is to find out if this combination is effective and safe. **You may be eligible if:** - You are 18 or older - You have a diagnosis of advanced soft-tissue sarcoma of a specific subtype included in this study - You have received at least one prior line of chemotherapy that didn't work or stopped working - You are in generally good health (ECOG performance status 0-1) **You may NOT be eligible if:** - You have bone sarcoma (osteosarcoma or chondrosarcoma) - You have received prior gemcitabine treatment - You have poor organ function (heart, kidney, liver) - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSelinexor 20 MG

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

DRUGGemcitabine

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


Locations(11)

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Clinico Universitario Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT06114004


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