RecruitingPhase 1NCT04595994

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

Sponsor

Grupo Espanol de Investigacion en Sarcomas

Enrollment

14 participants

Start Date

Sep 2, 2020

Study Type

INTERVENTIONAL

Conditions

Sarcoma,Soft Tissue

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining selinexor (a drug that blocks cancer cells from exporting certain proteins needed for survival) with gemcitabine (a chemotherapy drug) can treat advanced soft tissue sarcomas or osteosarcoma (bone cancer) that has not responded to prior treatment. **You may be eligible if...** - You are between 18 and 80 years old - You have advanced or metastatic undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft part sarcoma, or osteosarcoma confirmed by central pathology review - Your cancer has progressed in the last 6 months - You have received at least one prior systemic treatment - You have measurable disease on imaging - Your overall health/functional status is acceptable **You may NOT be eligible if...** - You have not received any prior treatment - Your cancer is not one of the specific subtypes included in this study - Your liver, kidney, or bone marrow function is inadequate - 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

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).