RecruitingPhase 2NCT04305548

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma


Sponsor

Italian Sarcoma Group

Enrollment

16 participants

Start Date

Sep 14, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Prospective, uncontrolled, investigator-initiated, phase II clinical study to explore the activity of trabectedin in a population of patients aged ≥16 years with progressive, advanced (locally advanced or metastatic)


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether trabectedin (a chemotherapy drug originally derived from a sea creature) can treat a rare and aggressive bone/cartilage cancer called mesenchymal chondrosarcoma that has a specific genetic change (HEY1-NCOA2 fusion) and has progressed on prior treatment. **You may be eligible if...** - You are at least 16 years old - You have a confirmed diagnosis of mesenchymal chondrosarcoma with the HEY1-NCOA2 genetic fusion (verified by a central lab) - Your cancer is locally advanced or has spread to other organs - Your cancer has progressed in the past 6 months - You have already received at least one prior chemotherapy containing anthracyclines (up to 3 prior treatment lines) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have not yet received any prior chemotherapy for advanced disease - You have had more than 3 prior lines of treatment - You are pregnant or breastfeeding - You have serious organ dysfunction 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

DRUGTrabectedin

Treatment with trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion


Locations(7)

Nuovo Ospedale di Prato

Prato, Firenze, Italy

Policlinico Universitario Campus Biomedico

Roma, RM, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, Italy

Istituto Ortopedico Rizzoli - Unit of Chemotherapy of Muscoloskeletal Tumors

Bologna, Italy

Fondazione IRCSS Istituto Nazionale dei Tumori

Milan, Italy

Ospedale Giaccone

Palermo, Italy

Istituti Fisioterapici Ospitalieri - Ospedale Regina Elena

Roma, Italy

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NCT04305548