EUCTR2009-010613-68-FR进行中（未招募）1 期
A phase II international multicentre randomised open label study of oral steroid sulphatase inhibitor BN83495 versus megestrol acetate (MA) in women with advanced or recurrent endometrial cancer
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 73
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. Provision of written informed consent prior to any study related procedures.
- •2. Post-menopausal or ovariectomised female patients over the age of 18 years.
- •3. Histologically confirmed diagnosis of metastatic, recurrent or adavanced endometrial cancer.
- •4. Not eligible for surgery or radiotherapy.
- •5. Document ER and/or PR positivity in the primary tumour.
- •6. No other history of malignant disease except treated basal cell or in situ cervical carcinoma.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status =2.
- •8. At least one measurable disease site (RECIST criteria version 1.0)
- •- minimum indicator lesion size: 20mm (conventional techniques) or 10mm (spiral CT scan)
- •- target lesions not situated in irradiated area
- •9. Life expectancy =6 months.
- •10. Adequate organ function as defined by the following criteria:
- •- Haemogolobin =10g/dL
- •- Absolute neutrophil count (ANC) =1500/µL
- •- Platelets =100,000/µl
- •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. Use of any investigational agent in the 4 weeks prior to
- •enrolment in this study
- •2. Prior systemic treatment for endometrial cancer (including
- •hormonal treatment, chemotherapy, antiangiogenic or targeted
- •3. Known central nervous system (CNS) metastases
- •4. Ongoing cardiac dysrhythmias of NCI CTC adverse event (AE)
- •grade =2, atrial fibrillation of any grade, QTcF interval
- •5. Patients with contraindications to MA including hypersensitivity
- •to one of the components of the drug product, any significant
- •arterial or venous thromboembolic event and/or uncontrolled
- •hypertension
- •6. Concomitant use of carbonic anhydrase II inhibitors
- •(e.g. acetazolamide, dichlorphenamide, methazolamide)
- •7. History of hypersensitivity to BN83495 or drugs with a similar
- •chemical structure.
- •8. Likely to require treatment during the study with drugs that are
- •not permitted by the study protocol (see Section 9.6).
- •9. Abnormal baseline findings, any other medical condition(s) or
- •laboratory findings that, in the opinion of the Investigator, might
- •jeopardise the patient’s safety or decrease the chance of
- •obtaining satisfactory data needed to achieve the objective(s) of
研究者
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