EUCTR2012-005546-38-AT进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
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 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.
- •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
排除标准
- •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. Concomitant use of prohibited therapy.
- •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 postoperative 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 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
研究者
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