Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01767155 | Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer | PHASE3 | COMPLETED | 511 | — | — | Apr 1, 2013 | Jan 30, 2017 | Jul 31, 2018 | 123 | United States, Austria +20 |
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.
| Arm | Type | Description |
|---|---|---|
| AEZS-108 / zoptarelin doxorubicin | EXPERIMENTAL | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles |
| doxorubicin/ standard chemotherapy | ACTIVE_COMPARATOR | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles |
| Name | Type | Description |
|---|---|---|
| AEZS-108 / zoptarelin doxorubicin | DRUG | 267 mg/m\^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles |
| doxorubicin | DRUG | 60 mg/m\^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles |
Inclusion Criteria: 1. Women ≥ 18 years of age 2. Histologically confirmed endometrial cancer 3. Advanced (FIGO stage III or IV), recurrent or metastatic disease. 4. Measurable or non-measurable disease that has progressed since last treatment. 5. 5\. Patients with advanced, recurrent or metastatic...