BN83495 Phase I in Post-menopausal Women
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|ClinicalTrials.gov Identifier: NCT01840488|
Recruitment Status : Completed
First Posted : April 25, 2013
Last Update Posted : April 25, 2013
The purpose of this study is to determine the optimal biological dose (OBD) of Irosustat (BN83495) in postmenopausal women with oestrogen receptor (ER) positive locally advanced or metastatic breast cancer with disease progression after prior hormonal therapy.
This study is designed to provide necessary information on safety and dose response of BN83495, when given by repeated once daily oral administration, while achieving a maximal STS inhibition and a maximal reduction in plasma oestradiol (E2) and adiol levels. The data obtained will be used to plan further clinical studies.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Irosustat (BN83495)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Escalation Study To Determine The Optimal Biological Dose Of BN83495 - An Oral Steroid Sulphatase Inhibitor - In Postmenopausal Women With Oestrogen-Receptor Positive Breast Cancer Whose Disease Progressed After Prior Therapy For Locally Advanced/Metastatic Disease|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Experimental: Irosustat (BN83495)
Single oral administration of irosustat
Drug: Irosustat (BN83495)
Three parts (A, B & C) open label, multiple cohort, dose escalation study with once daily administration of irosustat at 1, 5, 20, 40 and 80 mg. Patients treated in any cohort were not allowed to escalate to higher doses or be enrolled in another dosing cohort.
Part A - Single oral daily dose for 7 days, Part B - Repeated oral daily dose for 28 days and Part C - Repeated oral daily administration until disease progression.
- Change in percentage of steroid sulphatase (STS) inhibition in circulating Peripheral Blood Mononuclear Cells (PBMCs) after repeated daily therapy [ Time Frame: Days 15 and 36 ]The combined evaluation of ≥95% STS inhibition in PBMCs relative to Baseline after 7 and 28 days (Day 15 and Day 36,respectively) of continuous treatment and reduction in plasma E2 and adiol levels after 28 days of repeated daily administration, to determine the optimal biological dose (OBD) of irosustat.
- Percentage of steroid sulphatase (STS) inhibition in circulating Peripheral Blood Mononuclear Cells (PBMCs) after a single dose [ Time Frame: Day 8 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840488
|Institut Jules Bordet|
|Bruxelles, Belgium, B- 1000|
|Centre Paul Papin|
|Angers, France, 49000|
|Institut Georges François Leclerc|
|Dijon, France, 21079|
|Centre Eugène Marquis|
|Rennes, France, 35042|
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W12 0NN|
|Study Director:||Medical Director Oncology||Ipsen|