Objectives: Trabectedin (Yondelis) is approved for sarcoma treatment in many countries outside the United States. This open-label, phase III trial asks whether it can improve overall survival compared with dacarbazine in patients with advanced L-sarcoma.
Key entry or exclusion criteria: Patients must have advanced or spreading disease. They cannot have had prior exposure to the study drugs or have received the last dose of any therapy less than 3 weeks previously.
Locations: 73 sites.
Goal: 570 patients.
Study sponsor: Johnson & Johnson Pharmaceutical Research & Development LLC in collaboration with PharmaMar.
Links for more information: clinicaltrials.gov/ct2/show/study/NCT01343277
NIH clinical trials identifier: NCT01343277