EUCTR2009-010613-68-PL进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 80
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 with advanced or recurrent endometrial cancer.
- •3. Histologically confirmed diagnosis of endometrial carcinoma (primary tumour or metastasis).
- •4. Not eligible for surgery or radiotherapy alone, at Investigator’s discretion.
- •5. Document ER positivity in the primary tumour or in the metastatic tissue if the primary tumour is unavailable (ER positivity is defined by at least 10% positive cells).
- •6. No other history of malignant disease except treated basal cell or in situ cervical carcinoma in the previous 5 years. In case of previous malignant disease, pathological confirmation of metastatic endometrial cancer will be done at Investigator’s discretion.
- •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
- •- Serum creatinine =1.5x upper limit of normal (ULN) or calculated creatinine clearance =50 mL/min
- •- Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) =2.5x ULN or AST and ALT =5x ULN if liver metastases
- •- Total serum bilirubin =1.5x ULN
- •- Serum albumin =3.0 g/dL
- •- Cardiac function =New York Heart Association class II
- •11. Patients must have recovered from surgery, radiotherapy and toxicities of adjuvant chemotherapy treatment if applicable.
- •12. Patients must be willing and able to participate in a clinical trial (including the completion of all necessary study procedures).
- •13. Patients must be able to swallow oral medication.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
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 therapies) with the exception of chemotherapy in the adjuvant setting having been completed at least 6 months prior to randomisation.
- •3. Known central nervous system (CNS) metastases
- •4. Ongoing cardiac dysrhythmias of NCI-CTC adverse event (AE) grade =2, or atrial fibrillation of any grade, or QT interval corrected for heart rate using Fridericia's formulas (QTcF) interval >460 msec
- •5. Patients with contraindications to MA including hypersensitivity to one of the components of the drug product, any active arterial or venous thromboembolic event and/or uncontrolled hypertension. Patients receiving anticoagulation for a prior thromboembolic event may be enrolled in the study at Investigator’s discretion
- •6. Concomitant use of systemic 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 9.7).
- •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 the study.
研究者
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