At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 29 enrolled
Drug / intervention
Trabectedin +1 moredrug
Likely dose
Trabectedin 1.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Dec 24, 2007·Updated May 7, 2014
In Brief
A Phase 2 clinical trial evaluating Trabectedin and Dexamethasone for Liposarcoma,Myxoid. Completed, enrolled 29 participants across 8 sites in 3 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiposarcoma,Myxoid
CountriesFrance, Germany, United States
CollaboratorsPharmaMar
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2007
First PostedDec 2007
Primary CompletionJan 2010
TodayJul 2026
First PostedDec 24, 2007
Enrollment StartApr 1, 2007
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.5 years ago
Interventions
Trabectedindrug
Trabectedin 1.5 mg/m\^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin.
Dexamethasonedrug
Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion