Randomized controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer
This is an open-label, randomized, active-controlled, two-arm Phase iii study to compare the efficacy and safety of aeZS-108 and doxorubicin. The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.
Patients will be centrally randomized in a 1:1 ratio to receive treatment with either aeZS 108 (arm a) or doxorubicin (arm B).
arm a: The appropriate volume of reconstituted aeZS-108 solution will be diluted with physio-logical saline, such as to contain the desired amount of drug substance in an infusion volume of about 250 mL. The patient will receive aeZX-108 by an intravenous infusion over a period of about 2 hours for every Day 1 of 21-day (3-week) cycles.The proposed maximum duration is 9 cycles. an individual patient will be withdrawn from study as soon as disease progression indicates treatment failure or poor tolerability requires withdrawal.
arm B: The patient will receive 60 mg/m2 of doxorubicin by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles.
The primary efficacy outcome is overall survival (oS). overall survival will be defined as the days between randomization and the date of documented death for any cause. For patients whose survival status cannot be determined, their oS data will be censored at the last documented date that the patient is confirmed to be alive.
1. Women >= 18 years of age
2. Histologically confirmed endometrial adenocarcinoma of any subtype.
3. Advanced (FIGO stage III or IV), recurrent or metastatic disease.
4. Measurable or non-measurable disease that has progressed since last treatment.
5. Patients who have progressed after prior first line treatment with platinum/taxane based chemotherapy for advanced, recurrent or metastatic endometrial cancer.
6. Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.