EUCTR2007-002663-26-DE进行中（未招募）不适用
Antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin, in women with LHRH receptor positive gynecological tumors - AEZS-108 in patients with LHRH receptor positive gynecological tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 82
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) LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
- •3) Stratum A - ovarian cancer:
- •Histologically confirmed epithelial ovarian cancer
- •Advanced stage: FIGO III or IV or recurrent disease
- •Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
- •Previous treatment with a taxane-containing regimen
- •No previous anthracycline-based chemotherapy and not more than 2 previous chemotherapies or cytostatic therapies
- •At least one measurable target lesion (RECIST criteria)
- •CA125 level higher than twice the upper limit of normal range (GCIG criteria)
- •4) Stratum B - endometrium cancer:
- •Histologically confirmed endometrial cancer
- •Advanced (FIGO III or IV) or recurrent disease
- •No previous anthracycline-based chemotherapy
- •Previous endocrine therapy is allowed
- •At least one measurable target lesion according to RECIST criteria
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) History of allergic reaction to anthracycline or peptide drugs or to protein.
- •2) Patients with a history of unstable or newly diagnosed angina pectoris, documented history or current serious arrhythmia or CHF or recent myocardial infarction (within 6 months of enrolment).
- •3) Left ventricular ejection fraction (LVEF) < 60%.
- •4) Prior radiotherapy to the pericardial area > 35 Gy and more than 50% of bone marrow involved
- •5) Concomitant use of potentially cardiotoxic medication (e.g. calcium channel entry blockers).
- •6) Chemo-, immune-, hormone-, or radiotherapy within 4 weeks prior to entry (nitrosoureas or mitomycin C: 6 weeks).
- •7) Any non-compensated or uncontrolled non-malignant condition, such as active tuberculosis or any other active infection.
- •8) Any of the following laboratory values:
- •- thrombocyte count: < 100x109/L;
- •- absolute neutrophil count (ANC): < 1.5x109/L;
- •- hemoglobin: < 6.8 mmol/L (< 11 g/100 mL);
- •- ASAT, ALAT, AP: > 2.5 times upper limit of normal range (ULN): (> 5x ULN if clearly related to liver metastases);
- •- creatinine, bilirubin: > ULN.
- •9) Lactating female or female of child-bearing potential not employing adequate contraception.
- •10) Brain metastasis, leptomeningeal disease.
- •11) ECOG performance > 2.
- •12) Life expectancy < 3 months.
- •13) Neurological or psychiatric disease or drug or alcohol abuse which would interfere with the subjects’ proper completion of the protocol assignment.
- •14) Use of LHRH agonist or antagonist treatment within 6 months prior to entry.
- •15) Concomitant or recent (within 8 weeks) treatment with other investigational drug; or prior treatment with AEZS-108 (at any time)
- •16) Ovarian cancer patients without initial measurable disease must
- •not have received mouse antibodies (unless the CA 125 assay used has been shown not to be influenced by human antimouse antibodies (HAMA)) AND
- •17) not have had surgical or medical manipulation of their peritoneal or pleural cavity within 4 weeks preceding their screening for initial CA 125
研究者
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