Study Comparing AEZS-108 to Doxorubicin as a Second Line Therapy of Endometrial Cancer
This study is not yet open for participant recruitment.
Verified January 2013 by AEterna Zentaris
Sponsor:
AEterna Zentaris
Information provided by (Responsible Party):
AEterna Zentaris
ClinicalTrials.gov Identifier:
NCT01767155
First received: January 9, 2013
Last updated: January 11, 2013
Last verified: January 2013
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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: | March 2013 |
| Estimated Study Completion Date: | January 2016 |
| 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 maximun 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:
- 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.
- Patients who have progressed after prior first line treatment with platinum/taxane based chemotherapy for advanced, recurrent or metastatic endometrial cancer.
- Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.
Exclusion Criteria:
- ECOG 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, unstable angina, or uncontrolled arrhythmia within the past 6 months.
- Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % as measured by MUGA or ECHO.
- Planned concomitant use of potentially cardiotoxic medication
- Chemo-, immune-, hormone-, or radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
- Previous anthracycline-based chemotherapy.
- 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.
- Receipt of 2 or more prior 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 8 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767155
Contacts
| Contact: Daniel Croteau | 418-652-7669 ext 272 | DCroteau@aezsinc.com |
| Contact: Ines Altemose | 908-626-5510 | IAltemsose@aezsinc.com |
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: | January 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) UK:Medicines Control Agency (MCA) |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Adenoma 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 Neoplasms, Glandular and Epithelial Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013