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
- Conditions
- Advanced or recurrent endometrial cancerMedDRA version: 9.1Level: LLTClassification code 10014733Term: Endometrial cancer
- Registration Number
- EUCTR2009-010613-68-FR
- Lead Sponsor
- Ipsen Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 73
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
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 =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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method