Phase II study on trabectedin in adults and young adults HEY1-NOCA2 positive skeletal and extra-skeletal mesenchymal chondrosarcoma (MCS)

PI: Dr.ssa Silvia Stacchiotti 

This Clinical Trial is a single-arm, Phase 2 study for evaluating the activity of the anticancer drug trabectedin (already known for its activity in some soft tissue sarcomas characterized by chromosomal rearrangements) in young adult patients (aged ≥16 years) or adults affected by rearranged HEY1-NCOA2 mesenchymal chondrosarcoma (i.e. with the presence of the HEY1-NCOA2 gene fusion confirmed by molecular tests), of skeletal or extra-skeletal origin, in advanced stage of disease (locally advanced or metastatic, i.e. with a disease not amenable to surgery or radiotherapy), in progression.  

Patients eligible to participate in this study must have received at least one first-line chemotherapy treatment with anthracyclines, and all those enrolled in the study will all receive trabectedin and will be carefully followed with regular check-ups to evaluate the efficacy of the treatment and monitor any side effects. Patients will continue to receive trabectedin until disease progression, intolerable toxicity, clinical decision and/or patient willingness to discontinue study treatment. 

An optional biological analysis is also planned to analyze the correlation between the antitumor treatment response and the molecular and immunological profile.