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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   39233   clinical trials with a EudraCT protocol, of which   6427   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2004-004028-11
    Sponsor's Protocol Code Number:BIOV-211
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-02-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2004-004028-11
    A.3Full title of the trial
    A Phase II, Non-randomised, Study of Modrenal (Trilostane) in Pre-menopausal Women with Oestrogen Receptor Positive Breast Cancer who have Relapsed or are Refractory to Hormone Therapies of Tamoxifen, Goserelin and an Aromatase Inhibitor
    A.4.1Sponsor's protocol code numberBIOV-211
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioenvision Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D. name Modrenal 120mg Capsules
    D. of the Marketing Authorisation holderBioenvision Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameModrenal Capsules
    D.3.2Product code Trilostane
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTrilostane
    D.3.9.1CAS number 13647-35-3
    D.3.9.2Current sponsor codeTrilostane
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Oestrogen Receptor Positive Breast Cancer who have Relapsed or are Refractory to Hormone Therapies of Tamoxifen, Goserelin and an Aromatase Inhibitor
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10057654
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to determine the clinical benefit rate (CBR) defined as disease response or stabilisation [RECIST criteria] of up to 6 months treatment with trilostane 720 mg and concomitant hydrocortisone 20 mg in pre-menopausal women with hormone receptor positive breast cancer who have relapsed or are refractory to hormone therapies including tamoxifen, Goserelin and an AI.

    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    -To determine objective tumour response
    -To determine toxicity
    -To determine time to progressive disease
    -To determine duration of response
    -To determine performance status
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1) Patients must provide written informed consent prior to any study procedures being performed and according to local ethics committee guidelines
    2) Female patients aged over 18 years
    3) Patients must be pre-menopausal, defined as last menstrual period within 1 year of inclusion, or with oestrogen and follicle stimulating hormone (FSH)/luteinising hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy; patient must be on effective non-hormonal contraception
    4) Patients must have a histological diagnosis of oestrogen receptor positive breast cancer and have relapsed or are refractory to hormone therapies, which must have included tamoxifen, goserelin and an aromatase inhibitor (AI) prior to Screening
    5) Patients must have performance status ≤2 ECOG scale
    6) Patients must be suitable for hormone therapy in the investigator’s opinion
    7) Patients must have measurable disease according to the RECIST criteria
    8) Patients must have a life expectancy of >3 months
    9) Patients with bone metastases are eligible provided that they have evaluable sites of metastases that can be followed by x-ray, MRI/CT scan.
    10) Prior tamoxifen, goserelin and an aromatase inhibitor therapies must have failed (i.e. either relapsed or refractory)
    11) Patients must have haemoglobin ≥9.0 g/dL (after transfusion or Erythropoietin therapy if needed) at Screening
    12) Patients must have a white blood cell (WBC) count ≥3,500/mm3 at Screening
    13) Patients must have neutrophils ≥1,500/mm3 at Screening
    14) Patients must have platelets ≥100,000/mm3 at Screening
    15) Patients must have a creatinine ≤1.5 x upper limit of normal (ULN) for the testing laboratory, or a creatinine clearance ≥60 mL/minute at Screening
    16) Patients must have serum bilirubin ≤1.5 mg/dL at Screening
    17) Patients must have aspartate transaminase (AST), alanine transaminase (ALT) and alkaline phosphatase (ALP) ≤2 x ULN, or if liver metastases by ultrasound or magnetic resonance imaging (MRI) scan ≤5 x ULN at Screening
    E.4Principal exclusion criteria
    1) Patients with inflammatory breast cancer
    2) Patients with concurrent medical or psychiatric problems, unrelated to breast cancer, which would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
    3) Patients who are hypocortisolaemic
    4) Patients who have received treatment with another investigational therapy including hormonal therapy within 30 days or five half-lives (whichever is longer) prior to entry into the study
    5) Patients who are presently receiving or expect to require concurrent chemotherapy, immunotherapy, radiotherapy or chronic corticosteroid therapy. Patients who have received prior adjuvant chemotherapy will be eligible, provided the chemotherapy was administered prior to hormonal therapy and its use was stopped at least 6 months prior to study enrolment.
    6) Any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
    7) Patients with brain metastases
    8) Patients with severe concurrent illness
    9) Patients who previously participated in the study
    10) Patients with known adrenal insufficiency
    11) Patients who are pregnant or nursing
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with a clinical benefit (CBR) is defined as the proportion of patients with any of the following assessments using the Response Evaluation Criteria in Solid Tumours (RECIST) system at both the 3-month and 6 month visits:

    - Complete response (CR)-Disappearance of all target lesions
    - Partial Response (PR)-At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
    - Stable Disease (SD)-Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started

    CR and PR must be subsequently confirmed 4 weeks later.

    Secondary Objectives: Objective tumour response defined as the proportion of patients with an overall CR or PR at 3 or 6 months using the RECIST system; incidence and severity of toxicity [as assessed by the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0]; time to PD; duration of response from date of first response to date of PD; performance status, using Eastern Cooperative Oncology Group (ECOG) scale.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial is defined as the last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-02-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-05-22
    The status of studies in GB is no longer updated from 1.1.2021
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