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Clinical Trial Study Design | YONDELIS® (trabectedin) | HCP

YONDELIS® (trabectedin) Study Design

YONDELIS® was studied in a phase 3 randomized, open-label, active-controlled, multicenter trial of patients with unresectable, locally advanced or metastatic leiomyosarcomas (73%) or liposarcomas (27%).1



  • Median age was 56 years (range: 17 years to 81 years)
  • All patients had an ECOG score of ≤1
  • Previously treated with an anthracycline- and ifosfamide-containing regimen or an anthracycline-containing regimen and 1 additional cytotoxic chemotherapy regimen
  • The majority had received ≥2 prior lines of chemotherapy



(1.5 mg/m2 by 24-hour IV infusion once every 3 weeks)


(1,000 mg/m2 IV once every 3 weeks)

Efficacy Measures

Progression-free survival (PFS)
Overall survival (OS)
Objective response rate (ORR)
Duration of response (DOR)


ECOG = Eastern Cooperative Oncology Group.

IV = intravenous.


  1. YONDELIS® (trabectedin) [Prescribing Information]. Horsham, PA; Janssen Products, LP.