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

Primary Purpose

Endometrial Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AEZS-108 / zoptarelin doxorubicin
doxorubicin
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Hospital and Medical Center
  • USC Norris Hospital and LAC+USC Medical Center
  • University of California, Irvine - Medical Center
  • University of Colorado
  • Hartford Hospital
  • The Hospital of Central Connecticut
  • Moffitt Cancer Center
  • Northside Hospital
  • Northwestern University
  • University of Iowa Hospitals and Clinics
  • Women's Cancer Center
  • University of Maryland Greenebaum Cancer Center
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber Cancer Institute
  • Washington University School of Medecine
  • Memorial Sloan-Kettering Cancer Institute
  • Hope Women's Cancer Centers / Mission Hospital, Inc.
  • Levine Cancer Institute
  • Roger Maris Cancer Center
  • Ohio State University Wexner Medical Center
  • Peggy and Charles Oklahoma Cancer Center
  • Hollings Cancer Center, MUSC
  • Sanford Research/USD
  • University of Texas Southwestern Medical Center
  • University of Virginia
  • Inova Fairfax Hospitals
  • Henrico Doctor's Hospital
  • Froedtert & The Medical College of Wisconsin, Inc.
  • Medizinische Universität Innsbruck
  • Alexandrov National Cancer centre of Belarus
  • Minsk City Clinical Oncologic Dispensary
  • Mogilev Regional Clinical Oncologic Dispensary
  • Vitebsk Regional Clinical Oncologic Dispensary
  • Institut Jules Bordet
  • UZ Leuven - Campus Gasthuisberg
  • Hospital Centre Liege University_CHU Sart Tilman
  • CHWAPI
  • Clinical Center Banja Luka, Oncology Clinic
  • University Clinical Hospital Mostar, Oncology clinic
  • Clinical Centre University of Sarajevo
  • Specialized Hospital for Active Treatment in Obstetrics and Gynecology
  • Cross Cancer Institute
  • Princess Margaret Cancer Center
  • Hopital Notre Dame - CHUM
  • McGill University
  • Royal Victoria Hospital
  • Hotel Dieu de Quebec- CHUQ
  • Masarykův onkologický ústav
  • Fakultní nemocnice Olomouc
  • Všeobecná fakultní nemocnice v Praze
  • Copenhagen University Hospital "Rigshospitalet"
  • Herlev Hospital
  • Kuopio University Hospital
  • Tampere University Hospital
  • Turku University Central Hospital
  • Klinikum Frankfurt Höchst
  • Georg-August-Universität Göttingen, Universitäts-Frauenklinik, Abteilung für Gynäkologie und Geburtshilfe
  • Universitätsklinik und Poliklinik für Gynäkologie Martin Luther Universität Halle-Wittenberg
  • Universitätsklinikum Köln
  • University Clinic Münster
  • Klinik für Frauenheilkunde und Geburtshilfe der Universität Regensburg am Caritas-Krankenhaus St. Josef
  • Mater Misericordiae University Hospital
  • Mater Private Hospital
  • St James's Hospital
  • University Hospital Galway
  • Waterford Regional Hospital
  • Barzilai Medical Center
  • Rambam Health Care Campus
  • Hadassah Hospital
  • Davidoff Center, Rabin Medical Center
  • Oncology Institute Kaplan
  • Tel Aviv Sourasky Medical Center
  • Chaim Sheba Medical Center
  • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
  • Azienda Ospedaliero-Universitaria di Modena
  • Istituto Nazionale Tumori IRCCS
  • Istituto Oncologico Veneto, IRCCS
  • Azienda Ospedaliera Ospedali Riuniti Marche Nord
  • Policlinico A. Gemelli
  • Academic Medical Center
  • Maastricht University Medical Center (UMC)
  • Haukeland University Hospital
  • The Norwegian Radium Hospital
  • Helse Stavanger HF, Stavanger Universitetssjukhus
  • Bialostockie Centrum Onkologii
  • I Klinika Ginekologii Onkologicznej i Ginekologii
  • Wojewodzki Szpital Specjalistyczny
  • NZOZ Magodent, Szpital Onkologiczny
  • Centrum Terapii Współczesnej ul.
  • Oncolab
  • Spitalul Clinic Judetean Mures
  • Oncology Institute "Prof. Dr. I. Chiricuta"
  • Centru de Oncologie Sf. Nectarie
  • Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"
  • Oncomed
  • GAUZ "Republican Clinical Oncology Center"
  • FGBU "RONC n.a. N.N. Blokhin"
  • Nizhny Novgorod Regional Oncology Dispensary
  • Pyatigorsk Regional Oncology Dispensary
  • FGBU "NIIO n.a. N.N. Petrov"
  • Budget Institution of Health / Leningrad Regional Oncological Dispensary
  • Saint-Petersburg State Budgetary Institution Healthcare "City Clinical Oncology Center"
  • Republican Clinical Oncology Dispensary
  • Volgograd Regional Oncology Dispensary #3
  • Hospital Vall d´Hebron
  • MD Anderson cáncer center
  • Ramon Y Cajal Hospital
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Instituto Valenciano de Oncologia
  • Zina Memorial Cancer Hospital (LISSOD)
  • Municipal institution "Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4"
  • CCMP I Donetsk Regional Anticancer Center
  • Public health enterprise "Kharkov regional Clinical Oncological Center"
  • Kiev City Clinical Oncology Center
  • Zakarpatskyi Regional Clinical Oncology Dispensary
  • Vinnitsa Regional Clinical Oncology Dispensary
  • The Royal Marsden Hospital NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • University Hospitals Coventry and Warwickshire NHS Trust
  • St James's University Hospital
  • Imperial college Healthcare NHS Trust
  • Nottingham City Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AEZS-108 / zoptarelin doxorubicin

doxorubicin/ standard chemotherapy

Arm Description

267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles

60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Outcomes

Primary Outcome Measures

Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.
Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated.

Secondary Outcome Measures

Compare Efficacy Based on Objective Response Rate (ORR).
The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.
Compare Efficacy Based on Progression-free Survival (PFS).
Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression. Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used. During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks). A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR).
Compare Efficacy Based on Clinical Benefit Rate (CBR).
Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.

Full Information

First Posted
January 9, 2013
Last Updated
July 5, 2018
Sponsor
AEterna Zentaris
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1. Study Identification

Unique Protocol Identification Number
NCT01767155
Brief Title
Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
Acronym
ZoptEC
Official Title
Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
January 30, 2017 (Actual)
Study Completion Date
January 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open-label, randomized, active-controlled, two-arm Phase III study to compare the efficacy and safety of AEZS-108 and doxorubicin.
Detailed Description
The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AEZS-108 / zoptarelin doxorubicin
Arm Type
Experimental
Arm Description
267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles
Arm Title
doxorubicin/ standard chemotherapy
Arm Type
Active Comparator
Arm Description
60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
Intervention Type
Drug
Intervention Name(s)
AEZS-108 / zoptarelin doxorubicin
Other Intervention Name(s)
AEZS-108
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
Intervention Type
Drug
Intervention Name(s)
doxorubicin
Intervention Description
60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
Primary Outcome Measure Information:
Title
Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.
Description
Overall survival was defined as the elapsed time from randomization to death from any cause. For surviving patients, follow-up was to be censored at the date of last contact. The final analysis, which was event-based, was conducted after approximately 384 randomized patients had died. A log-rank test with an overall two sided Type I Error rate of 0.05 after taking the interim analyses into account was used to compare OS between the two treatment arms via a SAS (Statistical Analysis System) LIFETEST procedure. Kaplan Meier estimates were used to calculate median OS and the 95% confidence interval (CI) of the median OS. The proportion of patients alive at 6 and 12 months (from randomization date) and the 95% CIs for these estimated proportions were calculated.
Time Frame
From randomization to death from any cause. During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.
Secondary Outcome Measure Information:
Title
Compare Efficacy Based on Objective Response Rate (ORR).
Description
The ORR was defined as the sum of the Complete Response (CR) and Partial Response (PR). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.
Time Frame
3 years
Title
Compare Efficacy Based on Progression-free Survival (PFS).
Description
Progression-free survival (PFS): days between randomization and the date of documented progression or death for any cause that occurred up to the end of the study. For patients whose progression status could not be determined, their PFS data was censored for the last adequate progression assessment date that the patient was confirmed to have no progression. Response and progression were to be evaluated using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (uni-dimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes were to be used. During ongoing treatment, patients were to be re-evaluated for response every 3 cycles (i.e. every 9 weeks). A subsequent scan was obtained no earlier than 4 weeks following the initial documentation of an objective status of either complete response (CR) or partial response (PR).
Time Frame
During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.
Title
Compare Efficacy Based on Clinical Benefit Rate (CBR).
Description
Clinical benefit was defined as having stable disease (SD) or better lasting for at least 9 weeks. The CBR was analyzed using the same methods for the ORR analyses. The analysis of CBR (CR+PR+SD) was performed in the ITT (intention-to-treat) population. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) was to have a reduction in the short axis to <10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All responses were confirmed at least 4 weeks after the initial response was observed. Tumor assessments occurred every 3 cycles (± 7 days) during ongoing treatment then every 3 months (± 7 days) thereafter while the patient was on study. The last assessment occurred either when progression was confirmed or when approximately 384 randomized patients had died.
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion 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. 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Miller, MD
Organizational Affiliation
University of Texas Southwestern Medical Center, Dallas, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hani Gabra, MD
Organizational Affiliation
Imperial College London Hammersmith Campus, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
USC Norris Hospital and LAC+USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Irvine - Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868-3200
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
The Hospital of Central Connecticut
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Women's Cancer Center
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Washington University School of Medecine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Hope Women's Cancer Centers / Mission Hospital, Inc.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Peggy and Charles Oklahoma Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Hollings Cancer Center, MUSC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sanford Research/USD
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospitals
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22024
Country
United States
Facility Name
Henrico Doctor's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Froedtert & The Medical College of Wisconsin, Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medizinische Universität Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Alexandrov National Cancer centre of Belarus
City
Minsk
ZIP/Postal Code
223040
Country
Belarus
Facility Name
Minsk City Clinical Oncologic Dispensary
City
Minsk
Country
Belarus
Facility Name
Mogilev Regional Clinical Oncologic Dispensary
City
Mogilev
ZIP/Postal Code
212018
Country
Belarus
Facility Name
Vitebsk Regional Clinical Oncologic Dispensary
City
Vitebsk
ZIP/Postal Code
210603
Country
Belarus
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
UZ Leuven - Campus Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Hospital Centre Liege University_CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHWAPI
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
Clinical Center Banja Luka, Oncology Clinic
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Hospital Mostar, Oncology clinic
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Clinical Centre University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
Specialized Hospital for Active Treatment in Obstetrics and Gynecology
City
Pleven
Country
Bulgaria
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Notre Dame - CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hotel Dieu de Quebec- CHUQ
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Masarykův onkologický ústav
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Fakultní nemocnice Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha
ZIP/Postal Code
12851
Country
Czechia
Facility Name
Copenhagen University Hospital "Rigshospitalet"
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70029 KYS
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
Turku University Central Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Klinikum Frankfurt Höchst
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Georg-August-Universität Göttingen, Universitäts-Frauenklinik, Abteilung für Gynäkologie und Geburtshilfe
City
Göttingen
Country
Germany
Facility Name
Universitätsklinik und Poliklinik für Gynäkologie Martin Luther Universität Halle-Wittenberg
City
Halle
ZIP/Postal Code
06097
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50931
Country
Germany
Facility Name
University Clinic Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinik für Frauenheilkunde und Geburtshilfe der Universität Regensburg am Caritas-Krankenhaus St. Josef
City
Regensburg
Country
Germany
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Mater Private Hospital
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
Country
Ireland
Facility Name
Waterford Regional Hospital
City
Waterford
Country
Ireland
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Davidoff Center, Rabin Medical Center
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Oncology Institute Kaplan
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52661
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto, IRCCS
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
City
Pesaro
ZIP/Postal Code
61122
Country
Italy
Facility Name
Policlinico A. Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Maastricht University Medical Center (UMC)
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
The Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Helse Stavanger HF, Stavanger Universitetssjukhus
City
Stavanger
ZIP/Postal Code
NO-4068
Country
Norway
Facility Name
Bialostockie Centrum Onkologii
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
I Klinika Ginekologii Onkologicznej i Ginekologii
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Olsztyn
ZIP/Postal Code
10-561
Country
Poland
Facility Name
NZOZ Magodent, Szpital Onkologiczny
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Centrum Terapii Współczesnej ul.
City
Łódź
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Oncolab
City
Craiova
State/Province
Dolj County
ZIP/Postal Code
200385
Country
Romania
Facility Name
Spitalul Clinic Judetean Mures
City
Targu Mures
State/Province
Mures County
ZIP/Postal Code
540072
Country
Romania
Facility Name
Oncology Institute "Prof. Dr. I. Chiricuta"
City
Cluj Npaoca
ZIP/Postal Code
400015
Country
Romania
Facility Name
Centru de Oncologie Sf. Nectarie
City
Craiova
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"
City
Suceava
ZIP/Postal Code
720237
Country
Romania
Facility Name
Oncomed
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Facility Name
GAUZ "Republican Clinical Oncology Center"
City
Kazan
State/Province
Republic Of Tatarstan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FGBU "RONC n.a. N.N. Blokhin"
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Nizhny Novgorod Regional Oncology Dispensary
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
Pyatigorsk Regional Oncology Dispensary
City
Pyatigorsk
Country
Russian Federation
Facility Name
FGBU "NIIO n.a. N.N. Petrov"
City
Saint-Petersburg
Country
Russian Federation
Facility Name
Budget Institution of Health / Leningrad Regional Oncological Dispensary
City
St. Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Saint-Petersburg State Budgetary Institution Healthcare "City Clinical Oncology Center"
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary
City
Ufa
ZIP/Postal Code
450071
Country
Russian Federation
Facility Name
Volgograd Regional Oncology Dispensary #3
City
Volzhskiy
Country
Russian Federation
Facility Name
Hospital Vall d´Hebron
City
Barcelona
Country
Spain
Facility Name
MD Anderson cáncer center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Ramon Y Cajal Hospital
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28045
Country
Spain
Facility Name
Instituto Valenciano de Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Zina Memorial Cancer Hospital (LISSOD)
City
Plyuty
State/Province
Kiev Region
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Municipal institution "Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4"
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
CCMP I Donetsk Regional Anticancer Center
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Public health enterprise "Kharkov regional Clinical Oncological Center"
City
Kharkov
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Kiev City Clinical Oncology Center
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Zakarpatskyi Regional Clinical Oncology Dispensary
City
Uzhgorod
ZIP/Postal Code
88014
Country
Ukraine
Facility Name
Vinnitsa Regional Clinical Oncology Dispensary
City
Vinnitsa
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
The Royal Marsden Hospital NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
State/Province
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
St James's University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Imperial college Healthcare NHS Trust
City
London
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
36124638
Citation
Mathews C, Lorusso D, Coleman RL, Boklage S, Garside J. An Indirect Comparison of the Efficacy and Safety of Dostarlimab and Doxorubicin for the Treatment of Advanced and Recurrent Endometrial Cancer. Oncologist. 2022 Dec 9;27(12):1058-1066. doi: 10.1093/oncolo/oyac188. Erratum In: Oncologist. 2022 Nov 18;:
Results Reference
derived

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

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