Brief Title
The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer
Official Title
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
Brief Summary
This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA)
on progression free survival (PFS) in post menopausal patients with endometrial cancer.
Detailed Description
The Primary Objective in this study is to determine the antitumour efficacy of BN83495
measured by the percentage of women with advanced or recurrent endometrial cancer who have
neither progressed nor died after 6 months of treatment.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died
Secondary Outcome
Percentage of Participants With Adverse Event (AE)
Condition
Endometrial Cancer
Intervention
BN83495
Study Arms / Comparison Groups
A- BN 83495- 40mg
Description: After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
73
Start Date
August 2009
Completion Date
July 2013
Primary Completion Date
January 2012
Eligibility Criteria
Inclusion Criteria:
- Provision of written informed consent prior to any study related procedures
- Post-menopausal or ovariectomised female patients over the age of 18 years with
advanced or recurrent endometrial carcinoma
- Histologically confirmed diagnosis endometrial carcinoma (primary tumour or
metastasis)
- Not eligible for surgery or radiotherapy alone, at Investigator's discretion
- Documented Estrogen Receptor (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)
- 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
- Eastern Cooperative Oncology Group (ECOG) Performance status ≤2
- At least one measurable disease site
- minimum indicator lesion size: 20 mm (conventional techniques) or 10 mm (spiral
CT scan)
- target lesions not situated in irradiated area
- Life expectancy ≥6 months
- Adequate organ function as defined by the following criteria:
- Haemoglobin ≥10 g/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 AST and serum 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 (NYHA) class II
- Patients must have recovered from surgery, radiotherapy and toxicities of adjuvant
chemotherapy treatment if applicable
- Patients must be willing and able to participate in a clinical trial (including the
completion of all necessary study procedures)
- Patients must be able to swallow oral medication
Exclusion Criteria:
- Use of any investigational agent in the 4 weeks prior to enrollment in this study
- 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
- Known central nervous system (CNS) metastases
- Ongoing cardiac dysrhythmias of National Cancer Institute Common Toxicity Criteria
Adverse Events (NCI CTC AE) grade ≥2, atrial fibrillation of any grade, QTcF interval
>460 msec.
- Patients with contraindications to Megestrol Acetate (MA) including hypersensitivity
to one 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 the Investigator's discretion
- Concomitant use of carbonic anhydrase II inhibitors (e.g. acetazolamide,
dichlorphenamide, methazolamide)
- History of hypersensitivity to BN83495 or drugs with a similar chemical structure
- Likely to require treatment during the study with drugs that are not permitted by the
study protocol
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ipsen Medical Director, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00910091
Organization ID
X-55-58064-004
Secondary IDs
2009-010613-68
Responsible Party
Sponsor
Study Sponsor
Ipsen
Study Sponsor
Ipsen Medical Director, Study Director, Ipsen
Verification Date
January 2019