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

Phase 3
18 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

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

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. 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

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

4. History of myocardial infarction, unstable angina, or uncontrolled arrhythmia within
the past 6 months.

5. Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 %
as measured by MUGA or ECHO.

6. Planned concomitant use of potentially cardiotoxic medication

7. Chemo-, immune-, hormone-, or radiotherapy (including pre- or post-operative
brachytherapy) within 4 weeks prior to randomization.

8. Previous anthracycline-based chemotherapy.

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. Receipt of 2 or more prior chemotherapy regimens for advanced, recurrent, or
metastatic endometrial cancer.

14. Prior treatment with AEZS-108.

15. Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.

16. Malignancy within last 5 years except non-melanoma skin cancer.

17. Any concomitant disease or condition which would interfere with the subjects' proper
completion of the protocol assignment.

18. Concomitant or recent treatment with other investigational drug (within 8 weeks or 5
elimination half life times prior to anticipated start of study treatment).

19. Lack of ability or willingness to give informed consent.

20. Anticipated non-availability for study visits/procedures.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the overall survival (OS) of patients treated with AEZS-108 to the OS of patients treated with doxorubicin.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

David Scott Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Texas Southwestern Medical Center, Dallas, USA


United States: Food and Drug Administration

Study ID:

AEZS -108-050



Start Date:

April 2013

Completion Date:

January 2016

Related Keywords:

  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



University of Texas Southwestern Medical Center Dallas, Texas  
University of Maryland Greenebaum Cancer Center Baltimore, Maryland  21201