Study Comparing AEZS-108/ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) to Doxorubicin as a Second Line Therapy of Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by AEterna Zentaris
Sponsor:
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01767155
First received: January 9, 2013
Last updated: July 16, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Endometrial Cancer
Drug: AEZS-108 / zoptarelin doxorubicin
Drug: doxorubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by AEterna Zentaris:

Primary Outcome Measures:
  • Compare the overall survival (OS) of patients treated with AEZS-108 to the OS of patients treated with doxorubicin. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare efficacy based on objective response rate (ORR). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare efficacy based on progression-free survival (PFS). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Compare efficacy based on clinical benefit rate (CBR). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: April 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767155

Contacts
Contact: Herbert Sindermann, PhD +49 69 4 26 02 - 3429 HSindermann@aezsinc.com

  Show 116 Study Locations
Sponsors and Collaborators
AEterna Zentaris
Investigators
Principal Investigator: David Scott Miller, MD University of Texas Southwestern Medical Center, Dallas, USA
Principal Investigator: Hani Gabra, MD Imperial College London Hammersmith Campus, London, UK
  More Information

No publications provided

Responsible Party: AEterna Zentaris
ClinicalTrials.gov Identifier: NCT01767155     History of Changes
Other Study ID Numbers: AEZS -108-050
Study First Received: January 9, 2013
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Health and Medicines Authority
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Israel: Ministry of Health
Austria: Institute for Marketing Authorisation of Medicinal Products and Lifecycle Management
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Romania: National Medicines Agency
Bosnia and Herzegovina: Agency for Drugs and Medical Devices
Ukraine:State Expert Centre of Ministry of Health of Ukraine
Russia: Ministry of Health of the Russian Federation
Poland: Office for Registration of Medicinal Products, Medical Devices and Biologocal Products
Belarus:Ministry of HealthCare of the Republic of the Belarus
Spain:Spanish Agency for Medicines and Health Products
Norway:Norvegian Medicines Agency
Netherlands: Medicines Evaluation Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014