EUCTR2007-002663-26-BG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
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
相似试验
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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 tumorsHistologically confirmed malignancy of ovary or endometrium that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective andLHRH receptor positive tumor statuspositive receptor status determined by immunohistochemistry from primary tumorMedDRA version: 9.1Level: LLTClassification code 10007069Term: Cancer of endometrium stage IIIMedDRA version: 9.1Level: LLTClassification code 10007065Term: Cancer of endometrium recurrentMedDRA version: 9.1Level: LLTClassification code 10007070Term: Cancer of endometrium stage IVMedDRA version: 9.1Level: LLTClassification code 10057529Term: Ovarian cancer metastaticMedDRA version: 9.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentEUCTR2007-002663-26-DEAEterna Zentaris GmbH82
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2 期
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