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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT00910091
First received: May 21, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Endometrial Cancer
Drug: BN83495
Drug: Megestrol Acetate (MA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Determination of the antitumour efficacy of BN83495 [ Time Frame: after the last enrolled patient has been followed on treatment for at least 6 months or has progressed or died ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of safety and tolerability in this patient population [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • quality of life (QoL) using EuroQoL EQ-5D and an oncogeriatric assessment in patients > 65 years of age [ Time Frame: at each visit ] [ Designated as safety issue: No ]
  • pharmacodynamic effects of BN83495 on plasma steroid hormone levels [ Time Frame: screening, baseline, 8 weeks & end of treatment ] [ Designated as safety issue: No ]
  • pharmacokinetic profile of BN83495 by means of a population pharmacokinetic (PK) analysis [ Time Frame: baseline, 8 weeks & end of treatment ] [ Designated as safety issue: No ]
  • Clinical Benefit (CB): Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) ≥12 weeks [ Time Frame: after the last patient enrolled has been followed up for at least 6 months under treatment or until progression or death, and when all patients have progressed ] [ Designated as safety issue: No ]
  • Overall Response (OR): Complete Response (CR) + Partial Response (PR) [ Time Frame: after the last patient enrolled has been followed up for at least 6 months under treatment or until progression or death, and when all patients have progressed ] [ Designated as safety issue: No ]
  • Time to Progression (TTP): time from randomisation to first documentation of objective tumour progression [ Time Frame: after the last patient enrolled has been followed up for at least 6 months under treatment or until progression or death, and when all patients have progressed ] [ Designated as safety issue: No ]
  • Duration of Response (DR) in responders [ Time Frame: after the last patient enrolled has been followed up for at least 6 months under treatment or until progression or death, and when all patients have progressed ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: at 1 and 2 years following the randomisation of the last patient ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS): time from randomisation until objective tumour progression or death from any cause. [ Time Frame: after the last patient enrolled has been followed up for at least 6 months under treatment or until progression or death, and when all patients have progressed ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: August 2009
Study Completion Date: July 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: BN83495
BN83495 will be administered as a 40 mg tablet once a day orally
Active Comparator: 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
Drug: Megestrol Acetate (MA)
MA will be administered orally as 160mg daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910091

  Show 54 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Eric Chetaille, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT00910091     History of Changes
Other Study ID Numbers: X-55-58064-004, 2009-010613-68
Study First Received: May 21, 2009
Last Updated: July 16, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Moldova: Agentia Medicamentului
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Spain: AEMPS, Agencia Española de Medicamentos y Productos Sanitarios
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Lithuania: State Medicine Control Agency - Ministry of Health
Latvia: State Agency of Medicines

Keywords provided by Ipsen:
Endometrial cancer
Antitumour efficacy in women with advanced endometrial cancer

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Megestrol
Megestrol Acetate
Coumarins
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents
Anticoagulants
Hematologic Agents

ClinicalTrials.gov processed this record on August 26, 2014