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

NCT06114004 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-06-25

No results posted yet for this 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.

Conditions

  • Sarcoma,Soft Tissue

Interventions

DRUG

Selinexor 20 MG

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

DRUG

Gemcitabine

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

Sponsors & Collaborators

  • Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas

    lead OTHER

Principal Investigators

  • Javier MD Martín Broto · Hospital Universitario Fundación Jiménez Díaz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114004 on ClinicalTrials.gov