Trial with AEZS-108 in a certain stage of endometrial tumor

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 500

Inclusion Criteria

1. Woman ? 18 years of age
2. Histologically confirmed endometrial adenocarcinoma of any subtype.
3. Advanced (FIGO stage III or IV), recurrent or metastatic disease.
4. Measurable or non-measurable disease that has progressed since last treatment.
5. Patients who have progressed after prior first line treatment with platinum/taxane based chemotherapy for advanced, recurrent or metastatic endometrial cancer.
6. Availability of fresh or archival FFPE tumor specimens for analysis of LHRH receptor expression.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 250

Exclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status > 2
2. Inadequate hematologic, hepatic or renal function
- thrombocyte count: < 100 x 109/L;
- absolute neutrophil count (ANC): < 1.5 x 109/L;
- hemoglobin: < 5.6 mmol/L (< 9 g/dL);
- ASAT, ALAT, AP: > 2.5 times upper limit of normal range (ULN) (> 5x ULN if clearly related to liver metastases);
- creatinine, bilirubin: > 1.5x ULN.
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. Planned concomitant use of potentially cardiotoxic medication.
7. Chemo-, immune-, hormone-, or radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
8. Previous anthracycline-based chemotherapy.
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. Women of childbearing potential must agree to employ adequate contraception until 6 months after the last dose of study drug, defined as
- complete abstinence (Note: acceptable only as ?True abstinence?, i.e. when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal are not acceptable methods of contraception);
- any intrauterine device (IUD) with published data showing that the lowest expected failure rate is < 1% per year; or
- any other methods with published data showing that the lowest expected failure rate is less than 1% per year.
13. Subjects with known hypersensitivity to anthracyclines or peptide drugs, including LHRH agonists.
14. Receipt of 2 or more prior 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 8 weeks or 5 elimination half life times prior to anticipated start of study treatment).
20. and 21. Administrative reasons

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the overall survival (OS) of patients treated with AEZS-108 to the overall survival of patients treated with doxorubicin;Secondary Objective: Compare efficacy based on progression-free survival (PFS), overall response rate (ORR), and clinical benefit rate (CBR). Compare safety. Determine the impact of these regimens on patient-reported quality of life.<br>Sub-study (selected study sites only): Assess pharmacokinetics of AEZS-108.;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: The primary analysis of the primary efficacy variable will be based on the ITT population. The final overall survival analysis, which is event-based, will be conducted after approximately 384 randomized patients have died.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy based on progression-free survival (PFS), overall response rate (ORR), and clinical benefit rate (CBR).<br>Safety: adverse events, clinical laboratory and LVEF.<br>Quality of Life: EORTC QLQ30 + QLQ-EN24 questionnaires.;Timepoint(s) of evaluation of this end point: The primary analysis of the primary efficacy variable will be based on the ITT population. The final overall survival analysis, which is event-based, will be conducted after approximately 384 randomized patients have died.

Updated 4/24/2017

Trial with AEZS-108 in a certain stage of endometrial tumor

Recruitment & Eligibility

Study & Design

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