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Endometrial CancerPhase 3ZoptECNCT01767155

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

A Phase 3 study testing AEZS-108 / zoptarelin doxorubicin and doxorubicin in people with Endometrial Cancer, run by AEterna Zentaris at 123 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
AEZS-108 / zoptarelin doxorubicin and doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
511 participants
Where
123 sitesin 22 countries
Study dates
Apr 2013to 30 Jan 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 21Show fewer
  • 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.

Trial locations and contacts

123 sites in 22 countries.

123 sites in 22 countries

United States28 sites

  • Hope Women's Cancer Centers / Mission Hospital, Inc.

    Asheville, North Carolina, 28806

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Colorado

    Aurora, Colorado, 80045

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Hollings Cancer Center, MUSC

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Women's Cancer Center

    Covington, Louisiana, 70433

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9179

  • Inova Fairfax Hospitals

    Falls Church, Virginia, 22024

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • USC Norris Hospital and LAC+USC Medical Center

    Los Angeles, California, 90033

  • Froedtert & The Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Memorial Sloan-Kettering Cancer Institute

    New York, New York, 10065

  • Peggy and Charles Oklahoma Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of California, Irvine - Medical Center

    Orange, California, 92868-3200

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Henrico Doctor's Hospital

    Richmond, Virginia, 23229

  • Sanford Research/USD

    Sioux Falls, South Dakota, 57104

  • Washington University School of Medecine

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Russia9 sites

  • GAUZ "Republican Clinical Oncology Center"

    Kazan', Tatarstan Republic, 420029

  • FGBU "RONC n.a. N.N. Blokhin"

    Moscow, 115478

  • Nizhny Novgorod Regional Oncology Dispensary

    Nizhny Novgorod, 603081

  • Pyatigorsk Regional Oncology Dispensary

    Pyatigorsk

  • Budget Institution of Health / Leningrad Regional Oncological Dispensary

    Saint Petersburg, 191014

  • Saint-Petersburg State Budgetary Institution Healthcare "City Clinical Oncology Center"

    Saint Petersburg, 198255

  • FGBU "NIIO n.a. N.N. Petrov"

    Saint Petersburg

  • Republican Clinical Oncology Dispensary

    Ufa, 450071

  • Volgograd Regional Oncology Dispensary #3

    Volzhskiy

Other trials in Russia

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 78278

  • Rambam Health Care Campus

    Haifa, 31096

  • Hadassah Hospital

    Jerusalem, 91120

  • Davidoff Center, Rabin Medical Center

    Petah Tikva, 49100

  • Oncology Institute Kaplan

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52661

Other trials in Israel

Ukraine7 sites

  • Municipal institution "Dnipropetrovsk City Multidisciplinary Clinical Hospital No. 4"

    Dnipro, 49102

  • CCMP I Donetsk Regional Anticancer Center

    Donetsk, 83092

  • Public health enterprise "Kharkov regional Clinical Oncological Center"

    Kharkiv, 61070

  • Kiev City Clinical Oncology Center

    Kiev, 03115

  • Zina Memorial Cancer Hospital (LISSOD)

    Plyuty, Kyiv Oblast, 08720

  • Zakarpatskyi Regional Clinical Oncology Dispensary

    Uzhhorod, 88014

  • Vinnitsa Regional Clinical Oncology Dispensary

    Vinnitsa, 21029

Other trials in Ukraine

Canada6 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Notre Dame - CHUM

    Montreal, Quebec, H2L 4M1

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Hotel Dieu de Quebec- CHUQ

    Québec, G1R 2J6

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Germany6 sites

  • Universitätsklinikum Köln

    Cologne, 50931

  • Klinikum Frankfurt Höchst

    Frankfurt, 65929

  • Georg-August-Universität Göttingen, Universitäts-Frauenklinik, Abteilung für Gynäkologie und Geburtshilfe

    Göttingen

  • Universitätsklinik und Poliklinik für Gynäkologie Martin Luther Universität Halle-Wittenberg

    Halle, 06097

  • University Clinic Münster

    Münster, 48149

  • Klinik für Frauenheilkunde und Geburtshilfe der Universität Regensburg am Caritas-Krankenhaus St. Josef

    Regensburg

Other trials in Germany

Italy6 sites

  • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Azienda Ospedaliero-Universitaria di Modena

    Modena, 41124

  • Istituto Nazionale Tumori IRCCS

    Naples, 80131

  • Istituto Oncologico Veneto, IRCCS

    Padova, 35128

  • Azienda Ospedaliera Ospedali Riuniti Marche Nord

    Pesaro, 61122

  • Policlinico A. Gemelli

    Rome, 00168

Other trials in Italy

Romania6 sites

  • Oncology Institute "Prof. Dr. I. Chiricuta"

    Cluj Npaoca, 400015

  • Oncolab

    Craiova, Dolj, 200385

  • Centru de Oncologie Sf. Nectarie

    Craiova

  • Spitalul Clinic Judetean de Urgenta "Sf. Ioan cel Nou"

    Suceava, 720237

  • Spitalul Clinic Judetean Mures

    Târgu Mureş, Mureș County, 540072

  • Oncomed

    Timișoara, 300239

Other trials in Romania

Spain6 sites

  • Hospital Vall d´Hebron

    Barcelona

  • MD Anderson cáncer center

    Madrid, 28033

  • Ramon Y Cajal Hospital

    Madrid, 28034

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28045

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

United Kingdom6 sites

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Bebington, Wirral, CH63 4JY

  • University Hospitals Coventry and Warwickshire NHS Trust

    Coventry, CV2 2DX

  • St James's University Hospital

    Leeds, LS9 7TF

  • Imperial college Healthcare NHS Trust

    London

  • Nottingham City Hospital NHS Trust

    Nottingham, NG5 1PB

  • The Royal Marsden Hospital NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Ireland5 sites

  • Mater Misericordiae University Hospital

    Dublin, 7

  • Mater Private Hospital

    Dublin, 7

  • St James's Hospital

    Dublin, 8

  • University Hospital Galway

    Galway

  • Waterford Regional Hospital

    Waterford

Other trials in Ireland

Poland5 sites

  • Bialostockie Centrum Onkologii

    Bialystok, 15-027

  • Centrum Terapii Współczesnej ul.

    Lodz, 90-242

  • I Klinika Ginekologii Onkologicznej i Ginekologii

    Lublin, 20-081

  • Wojewodzki Szpital Specjalistyczny

    Olsztyn, 10-561

  • NZOZ Magodent, Szpital Onkologiczny

    Warsaw, 03-291

Other trials in Poland

Belarus4 sites

  • Alexandrov National Cancer centre of Belarus

    Minsk, 223040

  • Minsk City Clinical Oncologic Dispensary

    Minsk

  • Mogilev Regional Clinical Oncologic Dispensary

    Mogilev, 212018

  • Vitebsk Regional Clinical Oncologic Dispensary

    Vitebsk, 210603

Other trials in Belarus

Belgium4 sites

  • Institut Jules Bordet

    Brussels, 1000

  • UZ Leuven - Campus Gasthuisberg

    Leuven

  • Hospital Centre Liege University_CHU Sart Tilman

    Liège, 4000

  • CHWAPI

    Tournai, 7500

Other trials in Belgium

Bosnia and Herzegovina3 sites

  • Clinical Center Banja Luka, Oncology Clinic

    Banja Luka, 78000

  • University Clinical Hospital Mostar, Oncology clinic

    Mostar, 88000

  • Clinical Centre University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Czechia3 sites

  • Masarykův onkologický ústav

    Brno, 65653

  • Fakultní nemocnice Olomouc

    Olomouc, 77520

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12851

Other trials in Czechia

Finland3 sites

  • Kuopio University Hospital

    Kuopio, 70029 KYS

  • Tampere University Hospital

    Tampere, 33521

  • Turku University Central Hospital

    Turku, 20521

Other trials in Finland

Norway3 sites

  • Haukeland University Hospital

    Bergen, 5021

  • The Norwegian Radium Hospital

    Oslo, 0310

  • Helse Stavanger HF, Stavanger Universitetssjukhus

    Stavanger, NO-4068

Other trials in Norway

Denmark2 sites

  • Copenhagen University Hospital "Rigshospitalet"

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

Other trials in Denmark

Netherlands2 sites

  • Academic Medical Center

    Amsterdam, 1105

  • Maastricht University Medical Center (UMC)

    Maastricht, 6229 HX

Other trials in Netherlands

Austria1 site

  • Medizinische Universität Innsbruck

    Innsbruck, 6020

Other trials in Austria

Bulgaria1 site

  • Specialized Hospital for Active Treatment in Obstetrics and Gynecology

    Pleven

Other trials in Bulgaria

About this study

Official title: 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.

Read the detailed description

The study will include about 500 patients with endometrial cancer resistant to platinum/taxane-based chemotherapy.

Being tested
AEZS-108 / zoptarelin doxorubicin, doxorubicin
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AEZS-108 / zoptarelin doxorubicinDrug

    Also called AEZS-108

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

  • doxorubicinDrug

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

Study groups in NCT01767155
Study groupRoleWhat they receive
AEZS-108 / zoptarelin doxorubicinExperimental267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles
Receives: Drug: AEZS-108 / zoptarelin doxorubicin
doxorubicin/ standard chemotherapyActive comparator60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
Receives: Drug: doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (3)

  1. 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.

    Measured: 3 years

  2. 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).

    Measured: During ongoing treatment: response evaluation every 3 cycles. For patients gone of treatment: re-assessment every 12 weeks.

  3. 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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2013 (estimated)
  2. Study startApr 2013
  3. Primary completion30 Jan 2017
  4. Study completion30 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01767155
Sponsor's protocol ID
AEZS-108-050
Acronym
ZoptEC
Status last verified
Jan 2018
First submitted
9 Jan 2013
Last updated
31 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 36124638

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AEZS-108 / zoptarelin doxorubicin and doxorubicin in people with Endometrial Cancer, run by AEterna Zentaris at 123 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 sites in United States, Russia, Israel, Ukraine, Canada and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin. (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01767155, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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