This trial is active, not recruiting.

Condition endometrial cancer
Treatments aezs-108 / zoptarelin doxorubicin, doxorubicin
Phase phase 3
Sponsor AEterna Zentaris
Start date April 2013
End date December 2016
Trial size 500 participants
Trial identifier NCT01767155, AEZS-108-050


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.

United States Illinois
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles
aezs-108 / zoptarelin doxorubicin
267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles
(Active Comparator)
60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Primary Outcomes

Compare the overall survival (OS) of patients treated with AEZS-108 to the OS of patients treated with doxorubicin.
time frame: 3 years

Secondary Outcomes

Compare efficacy based on objective response rate (ORR).
time frame: 3 years
Compare efficacy based on progression-free survival (PFS).
time frame: 3 years
Compare efficacy based on clinical benefit rate (CBR).
time frame: 3 years

Eligibility Criteria

Female participants at least 18 years old.

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 endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed. 6. Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression. Exclusion Criteria: 1. ECOG performance status > 2. 2. Inadequate hematologic, hepatic or renal function 3. Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment. 4. History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months. 5. Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site's lower limit of normal) as measured by MUGA or ECHO. 6. Concomitant use of prohibited therapy (specified in protocol) 7. Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization. 8. Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation. 9. Anticipated ongoing concomitant anticancer therapy during the study. 10. History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection. 11. Brain metastasis, leptomeningeal disease. 12. Pregnant or lactating female or female of child-bearing potential not employing adequate contraception. 13. Subjects with known hypersensitivity to peptide drugs, including LHRH agonists. 14. Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer. 15. Prior treatment with AEZS-108. 16. Use of LHRH agonist or antagonist treatment within 6 months prior to randomization. 17. Malignancy within last 5 years except non-melanoma skin cancer. 18. Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment. 19. Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment). 20. Lack of ability or willingness to give informed consent. 21. Anticipated non-availability for study visits/procedures.

Additional Information

Official title Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
Principal investigator David S Miller, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by AEterna Zentaris.
Location data was received from the National Cancer Institute and was last updated in August 2016.