NCT04305548

Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

Phase II Study on Trabectedin in Advanced Rearranged Mesenchymal Chondrosarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Italian Sarcoma Group · Network
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Prospective, uncontrolled, multicenter, Italian, 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), HEY1-NCOA2 positive MCS) , pre-treated with anthracycline-based chemotherapy.

Conditions

• Mesenchymal Chondrosarcoma

Interventions

Type	Name	Description
DRUG	Trabectedin	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

Timeline

• Start date: 2021-09-14
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-03-12
• Last updated: 2026-03-27

Locations

7 sites across 1 country: Italy