NCT06114004

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Sarcoma,Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-28
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-11-02
• Last updated: 2025-06-25

Locations

11 sites across 1 country: Spain