Randomised controlled study comparing AEZS-108 with doxorubicin as second line therapy for locally advanced, recurrent or metastatic endometrial cancer - AEZS-108 and doxorubicin in patients with endometrial cancer

Aeterna Zentaris0 个研究点目标入组 14 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 14

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Woman * 18 years of age
•2. Histologically confirmed endometrial adenocarcinoma of any subtype
•a) Endometrioid carcinoma
•i. variant with squamous differentiations
•ii. Villoglandular variant
•iii. Secretory variant
•iv. Ciliated cell variant
•b) Mucinous adenocarcinoma
•c) Serous adenocarcinoma
•d) Clear cell adenocarcinoma
•e) Mixed cell adenocarcinoma
•f) Squamous cell carcinoma
•g) Transitional cell carcinoma
•h) Small cell carcinoma
•i) Undifferentiated carcinoma;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 with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regiment 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.

排除标准

•1. Eastern Cooperative Oncology Group (ECOG) performance status > 2
•2. Inadequate hematologic, hepatic or renal function
•- thromobocyte 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. Concomitant use of prohibited therapy (as specified in Section 6.3.2).
•7. Chemo-, immune- or hormonetherapy 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. 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 peptide drugs, including
•LHRH agonists.
•Lack of suitability for the trial:
•22. Malignancies arising from the uterine Cervix.
•23. Uterine sarcomas or mixed epithelial and mesenchymal tumors including carcinosarcoma, adenosarcoma, or carcinofibroma.
•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).
•Administrative reasons:
•20. Lack of availability for willingness to give informed consent.
•21. Anticipated non-availability for study visits/procedures.<

研究者

发起方

Aeterna Zentaris

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