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

NCT ID: NCT00910091

Last Updated: 2019-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2013-07-31

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A- BN 83495- 40mg

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

Group Type: EXPERIMENTAL

BN83495

Intervention Type: DRUG

BN83495 will be administered as a 40 mg tablet once a day orally

B- MA - 160mg

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

Group Type: ACTIVE_COMPARATOR

Megestrol Acetate (MA)

Intervention Type: DRUG

MA will be administered orally as 160mg daily

Interventions

BN83495

BN83495 will be administered as a 40 mg tablet once a day orally

Intervention Type: DRUG

Megestrol Acetate (MA)

MA will be administered orally as 160mg daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Onze-Lieve-Vrouwzickenhuis-Campus Aalst

Aalst, , Belgium

Centre Jules Bordet

Brussels, , Belgium

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

Sint Augustinus

Wilrijk, , Belgium

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Gynekologicko-porodnicka klinika

Prague, , Czechia

Krajska zdravotni s.r.o. - Masarykova nemocnice Usti nad Labem

Ústí nad Labem, , Czechia

Hôpital Jean Minjoz

Besançon, , France

Institut Bergonié

Bordeaux, , France

Centre François Baclesse

Caen, , France

Centre Oscar Lambret

Lille, , France

Centre Léon Bérard

Lyon, , France

Institut Paoli Calmettes

Marseille, , France

Institut Curie

Paris, , France

CHU Poitiers

Poitiers, , France

CHU Reims

Reims, , France

Institut Jean Godinot

Reims, , France

Centre Eugène Marquis

Rennes, , France

Centre Henri Becquerel

Rouen, , France

Centre René Gauducheau

Saint-Herblain, , France

Institut Gustave Roussy

Villejuif, , France

BAZ Megyei Kórház és Egyetemi Oktató Kórház, Sugártherápiás és Onkológiai Intézet

Miskolc, , Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Orvos-és Gyógyszerésztudományi Centrum

Szeged, , Hungary

Daugavpils Regional Hospital

Daugavpils, , Latvia

Piejuras Hospital, Oncologic Clinic

Liepāja, , Latvia

Riga Eastern CUH - Latvian Oncology Centre, Department No 9

Riga, , Latvia

Kauno universiteto medicinos kliniku onkologijos ligonine

Kaunas, , Lithuania

Vilniaus universiteto Onkologijos institutas

Vilnius, , Lithuania

Institutul Oncologic

Chisinau, , Moldova

Centrum Onkologii Ziemi Lubelskiej

Lublin, , Poland

Uniwersytet Medyczny

Poznan, , Poland

Oddział Ginekologii Onkologicznej Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Poznaniu

Poznan, , Poland

Centrum Onkologii Instytut Marii Sklodowskiej Curie

Warsaw, , Poland

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, , Russia

Medical Radiology Research Center of RAMS

Obninsk, , Russia

GUZ "Orenburg Regional Clinical Oncology Dispensary"

Orenburg, , Russia

Perm Regional Oncology Dispensary

Perm, , Russia

GUZ of Stavropol Territorial Clinical Oncological Dispensary, Pyatigorsk Branch

Pyatigorsk, , Russia

FGU "Research Institute of Oncology named after N.N.Petrov"

Saint Petersburg, , Russia

Saint-Petersburg GUZ City Clinical Oncology Dispensary

Saint Petersburg, , Russia

OOO "Sibmedcenter"

Tomsk, , Russia

H. Universitario Vall d´Hebron

Barcelona, , Spain

H. Universitario 12 de Octubre

Madrid, , Spain

H. Universitario Central de Asturias

Oviedo, , Spain

H. Clinico Universitario San Carlos

San Carlos, , Spain

Oblasnyi onkologichnyi klinichnyi dyspanser, misto Uzhgorod. Uzhgorods'kyi natsionalnyi universytet

Chernivtsi, , Ukraine

DU "Instytut medychnoi radiologii im. S.P. Grygorieva AMN Ukrainy"

Kharkiv, , Ukraine

DU "Natsionalnyi instytut raku", m. Kyiv

Kyiv, , Ukraine

Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno-diagnostychnyi tsentr

Lviv, , Ukraine

Beatson Oncology Centre, Gartnavel General Hospital

Glasgow, , United Kingdom

St James's University Hospital

Leeds, , United Kingdom

University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, , United Kingdom

University of Liverpool Clatterbridge Centre for Oncology

Liverpool, , United Kingdom

Christie Hospital NHS Trust

Manchester, , United Kingdom

Countries

Belgium; Czechia; France; Hungary; Latvia; Lithuania; Moldova; Poland; Russia; Spain; Ukraine; United Kingdom

Other Identifiers

2009-010613-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

X-55-58064-004

Identifier Type: -

Identifier Source: org_study_id