Brief Title
Zoptarelin Doxorubicin (AEZS 108) as Second Line Therapy for Endometrial Cancer
Official Title
Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Compare the Overall Survival (OS) of Patients Treated With AEZS-108 to the OS of Patients Treated With Doxorubicin.
Secondary Outcome
Compare Efficacy Based on Objective Response Rate (ORR).
Condition
Endometrial Cancer
Intervention
AEZS-108 / zoptarelin doxorubicin
Study Arms / Comparison Groups
AEZS-108 / zoptarelin doxorubicin
Description: 267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
511
Start Date
April 2013
Completion Date
January 30, 2017
Primary Completion Date
January 30, 2017
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
David S Miller, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01767155
Organization ID
AEZS-108-050
Responsible Party
Sponsor
Study Sponsor
AEterna Zentaris
Study Sponsor
David S Miller, MD, Principal Investigator, University of Texas Southwestern Medical Center, Dallas, USA
Verification Date
January 2018