CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 672 enrolled
Drug / intervention
Trabectedin +2 moredrug
Likely dose
Trabectedin 1.1 mg/m² IV over 3 hours every 3 weeks + DOXIL 30-50 mg/m² IV over 90 minutes every 3 weeksAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • ✓Exactly 1 prior platinum-based chemotherapy regimen
  • ✓Progression more than 6 months after initial chemotherapy (platinum-sensitive)
  • ✓ECOG performance status 0-2
Key exclusion· 5
  • ✕More than 1 prior chemotherapy regimen
  • ✕Progression within 6 months of initial chemotherapy (platinum-resistant)
  • ✕Prior exposure to anthracyclines
  • ✕Unable or unwilling to have central venous catheter

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113607
NCT00113607Phase 3Completed
CompareCT.gov

An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of DOXIL/CAELYX and YONDELIS With DOXIL/CAELYX Alone in Subjects With Advanced Relapsed Ovarian Cancer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Jun 10, 2005·Updated Jun 27, 2014

In Brief

A Phase 3 clinical trial evaluating Trabectedin, DOXIL, and 1 other intervention for Ovarian Cancer. Completed, enrolled 672 participants across 111 sites in 20 countries.

Detailed Summary

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, Netherlands, Poland, Russia, Singapore, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
CollaboratorsPharmaMar

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 10, 2005
Enrollment StartApr 1, 2005
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 21.1 years ago

Interventions

Trabectedindrug

Type=exact number, unit=mg/m2, number=1.1, form=solution, route=IV. Trabectedin will be administered over 3 hours every 3 weeks.

DOXILdrug

Type=exact number, unit=mg/m2, number=30, 50, form=solution, route=IV. DOXIL will be administered over 90 minutes every 4 weeks when administered alone (monotherapy) and every 3 weeks when administered with trabectedin.

Dexamethasonedrug

Type=exact number, unit=mg, number=20, form=solution, route=IV. Dexamethasone or its equivalent will be administered over 30 minutes prior to the DOXIL infusion.