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

Conditions

Advanced rearranged mesenchymal chondrosarcoma

Brief summary

Overall tumour Response Rate, according to RECIST v 1.1

Detailed description

Choi Response Rate, Overall Survival (OS), Progression Free Survival (PFS), Clinical Benefit Rate, Duration of response, Safety, Exploration of transcriptomic and genomic profile of responsive versus unresponsive tumors. Genomic, mRNA, miRNA expression pattern of a sizable number of responsive and unresponsive tumors will be analyzed and compared., Evaluation of efficacy of liquid biopsy (measure of HEY1-NCOA2 fusion in cell free DNA/RNA) in anticipating response/progression under treatment., Validazione dei target trascrizionali HEY1-NCOA2 coinvolti nella risposta MCS alla trabectedina mediante esperimenti in vitro.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGYondelis 1 mg powder for concentrate for solution for infusion.

DRUGYondelis 0.25 mg powder for concentrate for solution for infusion.

DRUGTrabectedina Teva 0

DRUG25 mg polvere per concentrato per soluzione per infusione

DRUGTrabectedina Teva 1 mg polvere per concentrato per soluzione per infusione

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall tumour Response Rate, according to RECIST v 1.1	—

Secondary

Measure	Time frame
Choi Response Rate, Overall Survival (OS), Progression Free Survival (PFS), Clinical Benefit Rate, Duration of response, Safety, Exploration of transcriptomic and genomic profile of responsive versus unresponsive tumors. Genomic, mRNA, miRNA expression pattern of a sizable number of responsive and unresponsive tumors will be analyzed and compared., Evaluation of efficacy of liquid biopsy (measure of HEY1-NCOA2 fusion in cell free DNA/RNA) in anticipating response/progression under treatment., Validazione dei target trascrizionali HEY1-NCOA2 coinvolti nella risposta MCS alla trabectedina mediante esperimenti in vitro.	—

Measure

Time frame

Choi Response Rate, Overall Survival (OS), Progression Free Survival (PFS), Clinical Benefit Rate, Duration of response, Safety, Exploration of transcriptomic and genomic profile of responsive versus unresponsive tumors. Genomic, mRNA, miRNA expression pattern of a sizable number of responsive and unresponsive tumors will be analyzed and compared., Evaluation of efficacy of liquid biopsy (measure of HEY1-NCOA2 fusion in cell free DNA/RNA) in anticipating response/progression under treatment., Validazione dei target trascrizionali HEY1-NCOA2 coinvolti nella risposta MCS alla trabectedina mediante esperimenti in vitro.

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Countries

Italy

Outcome results

None listed