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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 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion Criteria

  • Women ≥ 18 years of age
  • Histologically confirmed endometrial cancer
  • Advanced (FIGO stage III or IV), recurrent or metastatic disease.
  • Measurable or non-measurable disease that has progressed since last treatment.
  • 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.
  • Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.

  • ECOG performance status > 2.
  • Inadequate hematologic, hepatic or renal function
  • Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment.
  • History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.
  • 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.
  • Concomitant use of prohibited therapy (specified in protocol)
  • 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.
  • Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation.
  • Anticipated ongoing concomitant anticancer therapy during the study.
  • History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.
  • Brain metastasis, leptomeningeal disease.
  • Pregnant or lactating female or female of child-bearing potential not employing adequate contraception.
  • Subjects with known hypersensitivity to peptide drugs, including LHRH agonists.
  • Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer.
  • Prior treatment with AEZS-108.
  • Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
  • Malignancy within last 5 years except non-melanoma skin cancer.
  • Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment.
  • Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment).
  • Lack of ability or willingness to give informed consent.
  • Anticipated non-availability for study visits/procedures.


  • California

    • USC Norris Hospital and LAC+USC Medical Center, Los Angeles, California, 90033
  • Arizona

    • St. Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
  • Colorado

    • University of Colorado, Aurora, Colorado, 80045
  • Oklahoma

    • Peggy and Charles Oklahoma Cancer Center, Oklahoma City, Oklahoma, 73104
  • South Dakota

    • Sanford Research/USD, Sioux Falls, South Dakota, 57104
  • North Dakota

    • Roger Maris Cancer Center, Fargo, North Dakota, 58122
  • Iowa

    • University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242
  • Missouri

    • Washington University School of Medecine, St Louis, Missouri, 63110
  • Louisiana

    • Women's Cancer Center, Covington, Louisiana, 70433
  • Wisconsin

    • Froedtert & The Medical College of Wisconsin, Inc., Milwaukee, Wisconsin, 53226
  • Illinois

    • Northwestern University, Chicago, Illinois, 60611
  • Georgia

    • Northside Hospital, Atlanta, Georgia, 30342
  • Italy

    • Istituto Nazionale Tumori IRCCS, Napoli, 80131
    • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, 70124
    • Istituto Oncologico Veneto, IRCCS, Padova, 35128
  • Israel

    • Barzilai Medical Center, Ashkelon, 78278
  • Czech Republic

    • Fakultní nemocnice Olomouc, Olomouc, 77520
    • Masarykův onkologický ústav, Brno, 65653
  • Ukraine

    • Public health enterprise "Kharkov regional Clinical Oncological Center", Kharkov, 61070
    • Municipal institution "Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4", Dnepropetrovsk, 49102
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