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



Status:Completed
Conditions:Cervical Cancer, Cancer, Endometrial Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:April 2013
End Date:January 30, 2017

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

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.

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.
We found this trial at
29
sites
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Aurora, Colorado 80045
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Charleston, South Carolina 29425
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Charlotte, North Carolina 28211
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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303 East Superior Street
Chicago, Illinois 60611
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Covington, Louisiana 70433
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Falls Church, Virginia 22024
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820 4th St N
Fargo, North Dakota 58102
(701) 234-6161
Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Los Angeles, California 90033
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100 Grand St
New Britain, Connecticut 06050
(860) 224-5011
The Hospital of Central Connecticut The Hospital of Central Connecticut is dedicated to fostering, sustaining...
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Oklahoma City, Oklahoma 73104
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Richmond, Virginia 23294
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Saint Louis, Missouri 63110
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Sioux Falls, South Dakota 57104
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Tampa, Florida 33612
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