Trials / Recruiting

RecruitingNCT04595994

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

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

Status: Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 14 (estimated)

Sponsor: Grupo Espanol de Investigacion en Sarcomas · Academic / Other
Sex: All
Age: 18 Years – 80 Years
Healthy volunteers: Not accepted

Summary

Detailed description

Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma 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 4 different cohorts: Cohort 1: Undifferentiated pleomorphic sarcoma (UPS) Cohort 2: Leiomyosarcoma (LMS) Cohort 3: Alveolar soft-part sarcoma (ASPS) Cohort 4: Osteosarcoma Patients will be randomized for phase II part only (except in cohort 3) in an open-label way to receive selinexor in combination with gemcitabine versus gemcitabine alone

Conditions

Sarcoma,Soft Tissue

Interventions

Type	Name	Description
DRUG	Selinexor	For both interventional ( Selinexor and Gencitabine) Dose-limiting toxicity (DLT) will be applied only to either of the following toxicities occurring during the first treatment cycle (days 1-21).

Timeline

Start date: 2020-09-02
Primary completion: 2025-11-30
Completion: 2026-05-31
First posted: 2020-10-22
Last updated: 2024-01-23

Locations

6 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04595994. Inclusion in this directory is not an endorsement.