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

Sarcoma,Soft Tissue Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. In the Phase I part safety and toxicity of the combination will be assessed using a 3+3 design. The recommended dose for the Phase II will be determined. In the Phase II part there will be 2 different cohorts: Cohort 1: Leiomyosarcoma (LMS) Cohort 2: Malignant peripheral nerve sheath tumor (MPNST) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06114004
Study type Interventional
Source Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Contact Patricio Ledesma
Phone 971 439 900
Email ensayos@sofpromed.com
Status Recruiting
Phase Phase 2
Start date September 28, 2023
Completion date May 31, 2026
View Details
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