CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 579 enrolled
Drug / intervention
Trabectedin +1 moredrug
Likely dose
Not stated in 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.

Search/NCT01343277
NCT01343277Phase 3Completed
CompareCT.gov

A Randomized Controlled Study of YONDELIS (Trabectedin) or Dacarbazine for the Treatment of Advanced Liposarcoma or Leiomyosarcoma

Janssen Research & Development, LLC·interventional·Posted Apr 28, 2011·Updated Aug 26, 2016

In Brief

A Phase 3 clinical trial evaluating Trabectedin and Dacarbazine for Advanced Liposarcoma or Leiomyosarcoma. Completed, enrolled 579 participants across 88 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate whether overall survival for the trabectedin group is superior to the dacarbazine group for patients with advanced L-sarcoma (liposarcoma or leiomyosarcoma).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Liposarcoma or Leiomyosarcoma
CountriesAustralia, Brazil, New Zealand, United States
CollaboratorsPharmaMar

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2011
Enrollment StartJun 1, 2011
Primary CompletionJan 1, 2015
Study CompletionApr 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.2 years ago

Interventions

Trabectedindrug

Type=exactly number, unit=mg/m2, number=1.5, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.

Dacarbazinedrug

Type=exactly number, unit=g/m2, number=1, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.