Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer

Completed · Phase 3

Conditions studied: Endometrial Cancer

In brief

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

Key facts

Study ID

NCT01767155

Run by

AEterna Zentaris

People needed

511

Starts

2013-04-01

Expected to finish

2017-01-30

Last updated by the study team

2018-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Availability of fresh or archival FFPE (formalin-fixed and paraffin-embedded) tumor specimens for analysis of LHRH (luteinizing hormone releasing hormone) receptor expression.

You may not qualify if…

• ECOG (Eastern Cooperative Oncology Group) 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 (multigated radionuclide angiography) or ECHO (echocardiography).
• 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.

Where it is running

• USC Norris Hospital and LAC+USC Medical Center — Los Angeles, California, United States
• University of California, Irvine - Medical Center — Orange, California, United States
• University of Colorado — Aurora, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Women's Cancer Center — Covington, Louisiana, United States
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Washington University School of Medecine — St Louis, Missouri, United States
• Memorial Sloan-Kettering Cancer Institute — New York, New York, United States
• Hope Women's Cancer Centers / Mission Hospital, Inc. — Asheville, North Carolina, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Roger Maris Cancer Center — Fargo, North Dakota, United States
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Peggy and Charles Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
• Hollings Cancer Center, MUSC — Charleston, South Carolina, United States
• Sanford Research/USD — Sioux Falls, South Dakota, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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