At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 511 enrolled
Drug / intervention
AEZS-108 / zoptarelin doxorubicin +1 moredrug
Likely dose
AEZS-108 / zoptarelin doxorubicin 267 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.
Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
In Brief
A Phase 3 clinical trial evaluating AEZS-108 / zoptarelin doxorubicin and doxorubicin for Endometrial Cancer. Completed, enrolled 511 participants across 123 sites in 22 countries.
Detailed Summary
Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Cancer
CountriesAustria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 2013
Enrollment StartApr 2013
Primary CompletionJan 2017
TodayJul 2026
First PostedJan 14, 2013
Enrollment StartApr 1, 2013
Primary CompletionJan 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.5 years ago
Interventions
AEZS-108 / zoptarelin doxorubicindrug
267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles
doxorubicindrug
60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles