CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 121 enrolled
Drug / intervention
Trabectedin +2 moredrug
Likely dose
Trabectedin 1.5 milligramfrom 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/NCT00796120
NCT00796120Phase 3Completed

A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Nov 24, 2008·Updated Dec 10, 2015

In Brief

A Phase 3 clinical trial evaluating Trabectedin, Doxorubicin, and 1 other intervention for Sarcoma. Completed, enrolled 121 participants across 21 sites in 5 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesFrance, Germany, Spain, United Kingdom, United States
CollaboratorsPharmaMar

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartNov 1, 2008
Primary CompletionAug 1, 2012
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 17.6 years ago

Interventions

Trabectedindrug

Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

Doxorubicindrug

Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.

Ifosfamidedrug

Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.