Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer. (ZoptEC)

NCT01767155 Phase 3 COMPLETED Results posted

Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.

Details

Lead sponsor	AEterna Zentaris
Phase	Phase 3
Status	COMPLETED
Enrolment	511
Start date	2013-04
Completion	2017-01-30

Conditions

• Endometrial Cancer

Interventions

• AEZS-108 / zoptarelin doxorubicin
• doxorubicin

Primary outcomes

• Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. — From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.
  Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated.

Countries

United States, Austria, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Czechia, Denmark, Finland, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Romania, Russia, Spain, Ukraine, United Kingdom