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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767155
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : February 10, 2017
Information provided by (Responsible Party):
AEterna Zentaris

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: AEZS-108 / zoptarelin doxorubicin Drug: doxorubicin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Study Comparing AEZS-108 With Doxorubicin as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer.
Actual Study Start Date : April 2013
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: AEZS-108 / zoptarelin doxorubicin
267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles up to 9 cycles
Drug: AEZS-108 / zoptarelin doxorubicin
267 mg/m2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles

Active Comparator: doxorubicin/ standard chemotherapy
60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
Drug: doxorubicin
60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

Primary Outcome Measures :
  1. Compare the overall survival (OS) of patients treated with AEZS-108 to the OS of patients treated with doxorubicin. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Compare efficacy based on objective response rate (ORR). [ Time Frame: 3 years ]
  2. Compare efficacy based on progression-free survival (PFS). [ Time Frame: 3 years ]
  3. Compare efficacy based on clinical benefit rate (CBR). [ Time Frame: 3 years ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 tumor specimens for analysis of LHRH receptor expression.

Exclusion Criteria:

  1. ECOG 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 or ECHO.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01767155

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Sponsors and Collaborators
AEterna Zentaris
Principal Investigator: David S Miller, MD University of Texas Southwestern Medical Center, Dallas, USA
Principal Investigator: Hani Gabra, MD Imperial College London Hammersmith Campus, London, UK

Responsible Party: AEterna Zentaris Identifier: NCT01767155     History of Changes
Other Study ID Numbers: AEZS-108-050
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action