Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: AEZS-108 / zoptarelin doxorubicin; doxorubicin
Intervention description: 267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles; 60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 511.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        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 (formalin-fixed and paraffin-embedded) tumor
             specimens for analysis of LHRH (luteinizing hormone releasing hormone) receptor
             expression.

        Exclusion Criteria:

          1. ECOG (Eastern Cooperative Oncology Group) 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 (multigated
             radionuclide angiography) or ECHO (echocardiography).

          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.