The Study of Oral Steroid Sulphatase Inhibitor BN83495 Versus Megestrol Acetate (MA) in Women With Advanced or Recurrent Endometrial Cancer

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

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