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

NCT00910091 | Completed Phase 2 Results

• 2 other identifiers: X-55-58064-0042009-010613-68
• Study Type: interventional
• Target: 73
• Locations: 12 countries
• Sites: 54

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.

Conditions

Endometrial Cancer

Keywords

Endometrial cancer; Antitumour efficacy in women with advanced endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died

  Subject continuation in the study and Response Evaluation Criteria in Solid Tumours (RECIST) assessment has been based on investigator assessment and not on central review. The 6 month timepoint is defined as the treatment start date +183 days (26 weeks).

  Up to 6 months

Secondary Outcomes (11)

• Percentage of Participants With Adverse Event (AE)

  Up to Day 28 follow-up

• Tolerability of BN83495 Based on Length of Exposure

  Up to 2 years

• Tolerability of BN83495 Based on Cumulative Dose Administered

  Up to 2 years

• Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions

  Up to 2 years

• Percentage of Participants >65 Years of Age With No Change or Deterioration, Improvement of <10%, or Improvement of ≥10% on the EuroQoL Score

  Up to week 32

Study Arms (2)

A- BN 83495- 40mg

EXPERIMENTAL

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

Drug: BN83495

B- MA - 160mg

ACTIVE COMPARATOR

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

Drug: Megestrol Acetate (MA)

Interventions

BN83495 DRUG

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

A- BN 83495- 40mg

Megestrol Acetate (MA) DRUG

MA will be administered orally as 160mg daily

B- MA - 160mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (54)

Onze-Lieve-Vrouwzickenhuis-Campus Aalst

Aalst, 9300, Belgium

Location

Centre Jules Bordet

Brussels, 1000, Belgium

Location

UZ Leuven - Campus Gasthuisberg

Leuven, 3000, Belgium

Location

Sint Augustinus

Wilrijk, 2610, Belgium

Location

Fakultni nemocnice Olomouc

Olomouc, 775 20, Czechia

Location

Gynekologicko-porodnicka klinika

Prague, 100 34, Czechia

Location

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

Ústí nad Labem, 401 13, Czechia

Location

Hôpital Jean Minjoz

Besançon, 25000, France

Location

Institut Bergonié

Bordeaux, 33076, France

Location

Centre François Baclesse

Caen, 14076, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Paoli Calmettes

Marseille, 13273, France

Location

Institut Curie

Paris, 75005, France

Location

CHU Poitiers

Poitiers, 86021, France

Location

CHU Reims

Reims, 51056, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

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

Miskolc, H-3501, Hungary

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Orvos-és Gyógyszerésztudományi Centrum

Szeged, H-6720, Hungary

Location

Daugavpils Regional Hospital

Daugavpils, LV-5417, Latvia

Location

Piejuras Hospital, Oncologic Clinic

Liepāja, LV-3401, Latvia

Location

Riga Eastern CUH - Latvian Oncology Centre, Department No 9

Riga, LV-1079, Latvia

Location

Kauno universiteto medicinos kliniku onkologijos ligonine

Kaunas, LT-45434, Lithuania

Location

Vilniaus universiteto Onkologijos institutas

Vilnius, LT-08660, Lithuania

Location

Institutul Oncologic

Chisinau, MD-2025, Moldova

Location

Centrum Onkologii Ziemi Lubelskiej

Lublin, 20-090, Poland

Location

Uniwersytet Medyczny

Poznan, 60-535, Poland

Location

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

Poznan, 61-878, Poland

Location

Centrum Onkologii Instytut Marii Sklodowskiej Curie

Warsaw, 02-781, Poland

Location

Chelyabinsk Regional Clinical Oncology Dispensary

Chelyabinsk, 454087, Russia

Location

Medical Radiology Research Center of RAMS

Obninsk, 249036, Russia

Location

GUZ "Orenburg Regional Clinical Oncology Dispensary"

Orenburg, 460021, Russia

Location

Perm Regional Oncology Dispensary

Perm, 614066, Russia

Location

GUZ of Stavropol Territorial Clinical Oncological Dispensary, Pyatigorsk Branch

Pyatigorsk, 357502, Russia

Location

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

Saint Petersburg, 197758, Russia

Location

Saint-Petersburg GUZ City Clinical Oncology Dispensary

Saint Petersburg, 198255, Russia

Location

OOO "Sibmedcenter"

Tomsk, 634041, Russia

Location

H. Universitario Vall d´Hebron

Barcelona, 08036, Spain

Location

H. Universitario 12 de Octubre

Madrid, 28041, Spain

Location

H. Universitario Central de Asturias

Oviedo, 33006, Spain

Location

H. Clinico Universitario San Carlos

San Carlos, 28040, Spain

Location

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

Chernivtsi, 58000, Ukraine

Location

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

Kharkiv, 61024, Ukraine

Location

DU "Natsionalnyi instytut raku", m. Kyiv

Kyiv, 03022, Ukraine

Location

Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno-diagnostychnyi tsentr

Lviv, 79031, Ukraine

Location

Beatson Oncology Centre, Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

St James's University Hospital

Leeds, LS9 7TF, United Kingdom

Location

University Hospitals of Leicester, Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

University of Liverpool Clatterbridge Centre for Oncology

Liverpool, CH63 4JY, United Kingdom

Location

Christie Hospital NHS Trust

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

irosustat; Megestrol Acetate

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Medical Director, Oncology
• Organization: Ipsen

clinical.trials@ipsen.com

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 29, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: July 1, 2013
• Last Updated: January 30, 2019
• Results First Posted: September 30, 2015

Record last verified: 2019-01

Locations

BE (4); RU (8); ES (4); GB (5); LI (2); FR (14); PL (4); UA (4); LA (3); MO (1); CZ (3); HU (2)