CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 581 enrolled
Drug / intervention
Trabectedin +3 moredrug
Likely dose
Trabectedin 1.1 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.

Search/NCT01846611
NCT01846611Phase 3Completed
CompareCT.gov

A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Janssen Research & Development, LLC·interventional·Posted May 3, 2013·Updated Apr 1, 2019

In Brief

A Phase 3 clinical trial evaluating Trabectedin, DOXIL, and 1 other intervention for Ovarian Neoplasms and 2 related conditions. Completed, enrolled 581 participants across 138 sites in 10 countries.

Detailed Summary

The purpose of this study is to assess the efficacy and safety of trabectedin+DOXIL as a third-line chemotherapy regimen (treatment) in patients with platinum-sensitive advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer who received 2 previous lines of platinum-based chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms
CountriesAustralia, China, Israel, New Zealand, Poland, Russia, South Africa, Switzerland, United Kingdom, United States
CollaboratorsPharmaMar

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2013
Enrollment StartOct 16, 2013
Primary CompletionJan 18, 2018
Study CompletionNov 16, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.2 years ago

Interventions

Trabectedindrug

1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.

DOXILdrug

30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.

Dexamethasonedrug

20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.

DOXILdrug

50 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.