Estudio en fase II, internacional, multicéntrico, aleatorizado, abierto, de BN83495, un inhibidor oral de la esteroide sulfatasa, frente a acetato de megestrol (AM) en mujeres con cáncer endometrial avanzado o recidivante.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.

Ipsen Pharma0 个研究点目标入组 80 人开始时间: 2009年7月2日最近更新: 2012年5月15日

适应症

试验速览

暂无简介。

•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 < or = 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 > or = 6 months.
•10. Adequate organ function as defined by the following criteria:
•- Haemogolobin > or = 10g/dL
•- Absolute neutrophil count (ANC) > or = 1500/µL
•- Platelets > or = 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

•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)
•3. Known central nervous system (CNS) metastases
•4. Ongoing cardiac dysrhythmias of NCI CTC adverse event (AE) grade > or = 2, atrial fibrillation of any grade, QTcF interval >460 msec
•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 the study.

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