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Endometrial CancerPhase 2NCT00910091

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

A Phase 2 study testing BN83495 and Megestrol Acetate (MA) in people with Endometrial Cancer, run by Ipsen at 54 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
BN83495 and Megestrol Acetate (MA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
54 sitesin 12 countries
Study dates
Aug 2009to Jul 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

54 sites in 12 countries.

54 sites in 12 countries

France14 sites

  • Hôpital Jean Minjoz

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33076

  • Centre François Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13273

  • Institut Curie

    Paris, 75005

  • CHU Poitiers

    Poitiers, 86021

  • CHU Reims

    Reims, 51056

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Gauducheau

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Russia8 sites

  • Chelyabinsk Regional Clinical Oncology Dispensary

    Chelyabinsk, 454087

  • Medical Radiology Research Center of RAMS

    Obninsk, 249036

  • GUZ "Orenburg Regional Clinical Oncology Dispensary"

    Orenburg, 460021

  • Perm Regional Oncology Dispensary

    Perm, 614066

  • GUZ of Stavropol Territorial Clinical Oncological Dispensary, Pyatigorsk Branch

    Pyatigorsk, 357502

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

    Saint Petersburg, 197758

  • Saint-Petersburg GUZ City Clinical Oncology Dispensary

    Saint Petersburg, 198255

  • OOO "Sibmedcenter"

    Tomsk, 634041

Other trials in Russia

United Kingdom5 sites

  • Beatson Oncology Centre, Gartnavel General Hospital

    Glasgow, G12 0YN

  • St James's University Hospital

    Leeds, LS9 7TF

  • University Hospitals of Leicester, Leicester Royal Infirmary

    Leicester, LE1 5WW

  • University of Liverpool Clatterbridge Centre for Oncology

    Liverpool, CH63 4JY

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

Other trials in United Kingdom

Belgium4 sites

  • Onze-Lieve-Vrouwzickenhuis-Campus Aalst

    Aalst, 9300

  • Centre Jules Bordet

    Brussels, 1000

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000

  • Sint Augustinus

    Wilrijk, 2610

Other trials in Belgium

Poland4 sites

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Uniwersytet Medyczny

    Poznan, 60-535

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

    Poznan, 61-878

  • Centrum Onkologii Instytut Marii Sklodowskiej Curie

    Warsaw, 02-781

Other trials in Poland

Spain4 sites

  • H. Universitario Vall d´Hebron

    Barcelona, 08036

  • H. Universitario 12 de Octubre

    Madrid, 28041

  • H. Universitario Central de Asturias

    Oviedo, 33006

  • H. Clinico Universitario San Carlos

    San Carlos, 28040

Other trials in Spain

Ukraine4 sites

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

    Chernivtsi, 58000

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

    Kharkiv, 61024

  • DU "Natsionalnyi instytut raku", m. Kyiv

    Kyiv, 03022

  • Lvivskyi derzhavnyi onkologichnyi regionalnyi likuvalno-diagnostychnyi tsentr

    Lviv, 79031

Other trials in Ukraine

Czechia3 sites

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Gynekologicko-porodnicka klinika

    Prague, 100 34

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

    Ústí nad Labem, 401 13

Other trials in Czechia

Latvia3 sites

  • Daugavpils Regional Hospital

    Daugavpils, LV-5417

  • Piejuras Hospital, Oncologic Clinic

    Liepāja, LV-3401

  • Riga Eastern CUH - Latvian Oncology Centre, Department No 9

    Riga, LV-1079

Other trials in Latvia

Hungary2 sites

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

    Miskolc, H-3501

  • Szegedi Tudományegyetem Szent-Györgyi Albert Orvos-és Gyógyszerésztudományi Centrum

    Szeged, H-6720

Other trials in Hungary

Lithuania2 sites

  • Kauno universiteto medicinos kliniku onkologijos ligonine

    Kaunas, LT-45434

  • Vilniaus universiteto Onkologijos institutas

    Vilnius, LT-08660

Other trials in Lithuania

Moldova1 site

  • Institutul Oncologic

    Chisinau, MD-2025

Other trials in Moldova

About this study

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

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.

Read the 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.

Being tested
BN83495, Megestrol Acetate (MA)
Keywords
Endometrial cancer, Antitumour efficacy in women with advanced endometrial cancer
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BN83495Drug

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

  • Megestrol Acetate (MA)Drug

    MA will be administered orally as 160mg daily

Study groups in NCT00910091
Study groupRoleWhat they receive
A- BN 83495- 40mgExperimentalAfter 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
Receives: Drug: BN83495
B- MA - 160mgActive comparatorAfter 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
Receives: Drug: Megestrol Acetate (MA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 6 months

Secondary outcomes (11)

  1. Percentage of Participants With Adverse Event (AE)

    Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening/disabling and Grade 5: Death

    Measured: Up to Day 28 follow-up

  2. Tolerability of BN83495 Based on Length of Exposure

    Length of exposure includes interruptions.

    Measured: Up to 2 years

  3. Tolerability of BN83495 Based on Cumulative Dose Administered

    Cumulative dose is the actual total dose administered.

    Measured: Up to 2 years

  4. Tolerability of BN83495 Based on Dose Interruptions and Reason for Interruptions

    Percentage of participants who had dose interruptions and reason for interruptions as AE, study treatment forgotten, and other reasons.

    Measured: Up to 2 years

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

    EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) is a participant answered questionnaire scoring 5 dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.

    Measured: Up to week 32

  6. Percentage of Participants With Clinical Benefit [Including Completed Response (CR), Partial Response (PR), and Stable Disease (SD)] ≥12 Weeks

    CR: Disappearance of all known disease \& no new sites / disease related symptoms confirmed at least 12 weeks after initial documentation. Disappearance of all non-target lesions. Normalization of tumor marker level confirmed at least 12 weeks after initial documentation.

    PR: Minimum 30% decrease in sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 12 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above normal limits.

    RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.

    Measured: Up to 2 years

  7. Percentage of Participants With Overall Response (OR) Including CR and PR

    Measured: Up to 2 years

  8. Percentage of Participants With First Documentation of Objective Tumour Progression From Randomisation

    Measured: Up to 2 years

  9. Duration of Response (DR) in Responders

    DR is defined as period from the time that measurement criteria are first met for CR or PR until first date of documented Progressive Disease (PD) or death. DR was assessed in participants with a best overall response of CR or PR.

    Measured: At 2 years

  10. Overall Survival (OS)

    OS is defined as the time from the date of enrollment to the date of death due to any cause.

    Measured: At 2 years

  11. Progression Free Survival (PFS): Time From Randomisation Until Objective Tumour Progression or Death From Any Cause

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionJan 2012
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00910091
Sponsor's protocol ID
X-55-58064-004
Other IDs
2009-010613-68, 2009
Status last verified
Jan 2019
First submitted
21 May 2009
Last updated
30 Jan 2019
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BN83495 and Megestrol Acetate (MA) in people with Endometrial Cancer, run by Ipsen at 54 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in France, Russia, United Kingdom, Belgium, Poland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Women With Advanced or Recurrent Endometrial Cancer Who Have Neither Progressed Nor Died (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00910091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

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