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    Summary
    EudraCT Number:2011-005680-25
    Sponsor's Protocol Code Number:C/22/2011
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-005680-25
    A.3Full title of the trial
    A Phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER positive locally advanced or metastatic breast cancer patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate whether adding a new hormone treatment for breast cancer, called Irosustat, to current hormone treatment (aromatase inhibitor) can affect the growth of breast cancer.
    A.3.2Name or abbreviated title of the trial where available
    IRIS v1.0
    A.4.1Sponsor's protocol code numberC/22/2011
    A.5.4Other Identifiers
    Name:IPSEN Study Protocol NumberNumber:X-52-58064-010
    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 SponsorImperial College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportBeaufour IPSEN Industrie, Pharmaceutics - CTSU
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImperial College London
    B.5.2Functional name of contact pointDr Sadie Reed
    B.5.3 Address:
    B.5.3.1Street AddressImperial Clinical Trials Unit - Cancer, Charing Cross campus
    B.5.3.2Town/ city1st Floor - Medical Oncology,
    B.5.3.3Post codeW6 8RF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44(0)20 33130648
    B.5.5Fax number+44(0)20 8741 0731
    B.5.6E-mailiris-trial@imperial.ac.uk
    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 No
    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 nameIrosustat
    D.3.2Product code BN83495
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    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 INNIrosustat
    D.3.9.1CAS number 288628-05-7
    D.3.9.2Current sponsor codeIrosustat
    D.3.9.3Other descriptive nameBN83495, also known as STX64 or 667-coumate
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic breast cancer
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread to another part of the body or has come back in the same area it started.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess if adding Irosustat to existing aromatase inhibitor (AI) treatment in patients who have progressed on an AI can control cancer growth by either stopping its growth or reducing its size for a period of 6 months.
    E.2.2Secondary objectives of the trial
    1) To investigate the length of the effectiveness of adding Irosustat to aromatase inhibitor treatment based on the tumour response RECIST criteria (a set of published rules that define when cancer patients improve, stay the same or worsen during treatments).

    2) To assess the effectiveness of adding Irosustat to an aromatase inhibitor based on the objective response rate (how well the tumour is responding to treatment).

    3) To assess the effectiveness of the addition of Irosustat to aromatase inhibitor treatment based on progression free survival (length of time during and after medication in which the cancer does not get worse).

    4) To assess the safety and tolerability of Irosustat when used with an aromatase inhibitor by collecting any signs or symptoms the patients may experience.

    5) To measure the effect that adding Irosustat to aromatase inhibitor treatment has on the body by measuring the changes in hormone levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent prior to admission to this study.
    2. Aged ≥ 25 years of age.
    3. Histologically confirmed ER+ve primary or metastatic breast cancer according to local criteria.
    4. Locally advanced1 or metastatic breast cancer treated with 1st line AI treatment with either:
    A documented objective response (CR/PR) at any point after beginning on a 1st line AI prior to disease progression.
    OR
    Disease stabilisation (SD) for at least 6 months on a 1st line AI prior to disease progression.
    5. Postmenopausal as defined by any of the following criteria:
    a. Amenorrhoea for at least 6 months prior to study entry and estradiol and LH/FSH in the postmenopausal range on local laboratory analysis whilst taking a 3rd genera-tion AI during the screening phase of the study.
    b. Amenorrhoea during combination treatment with ovarian suppression (e.g. goserelin) and an AI in which case estradiol should be below the limit of de-tection of the standard local laboratory assay during the screening phase of the study.
    6. ECOG performance status 0 to 2.
    7. Measurable and/or evaluable sites of locally advanced or metastatic disease that can be accu-rately assessed by CT/MRI scan at baseline and follow up visits (RECIST v1.1).
    8. Adequate organ function as defined by:
    a.Haemoglobin (Hb) ≥ 9 g/dL
    b. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    c. Platelet count (Plts) ≥ 100 x 109/L
    d. White Blood Cell (WBC) ≥ 3.0 x 109/L
    e. Serum albumin ≤ 1.5 ULN
    f. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 x ULN if no demonstrable liver metastases or ≤ 5 x ULN in the presence of liver metastases.
    g. ALP ≤ 5 x ULN
    h. Total bilirubin ≤ 1.5 x ULN if no demonstrable liver metastases or ≤ 3 x ULN in the pres-ence of liver metastases.
    i. Creatinine ≤ 1.5 x ULN or creatinine clearance >50ml/min.
    9. Life expectancy of ≥3 months.

    NOTE:
    1. Locally advanced cancer where it is not amenable or possible to have surgery or treatment with curative intent.
    2. Patients with bone metastasis are eligible provided they have evaluable metastases sites that can be followed (X-Ray or MRI/CT scanning). Patients on established bisphosphonate treatment for at least 3 months are eligible for entry into the trial and are allowed to continue with bisphosphonate treatment.
    E.4Principal exclusion criteria
    1. HER2 positive cancer.
    2. Discontinuation of current AI therapy for > 21 days prior to study entry*.
    3. Rapidly progressive, life-threatening metastases, including any of the following:
    a) Patients with active parenchymal brain or leptomeningeal involvement
    b) Symptomatic lymphangitis carcinomatosis
    c) Extensive visceral metastases requiring chemotherapy.
    4. Patients with a history of another primary malignancy within 5 years prior to starting study treatment, except adequately treated basal or squamous cell carcinoma of the skin, carcinoma in site and the disease under study.
    5. More than one prior line of chemotherapy for locally advanced or metastatic disease.
    6. AI therapy given in combination with another endocrine agent with the exception of a GnRH agonist.
    7. Radiotherapy to measurable lesion within 2 months of treatment start.
    8. Systemic corticosteroids for ≥ 15 days within the last 4 weeks.
    9. Evidence of uncontrolled active infection.
    10. Evidence of significant medical condition or laboratory finding which, in the opinion of the Inves-tigator, makes it undesirable for the patient to participate in the trial.
    11. Concurrent therapy with any other investigational agent.
    12. Concomitant use within 14 days prior to commencement of treatment of:
    a) Rifampicin and other CYP2C and 3A inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and St. John’s Wort
    b) Systemic carbonic anhydrase inhibitors
    13. Any of the following cardiac criteria:
    a) Mean resting corrected QT interval (QTcf) >450 ms as calculated by Fridericia's formula obtained from 3 electrocardiograms (ECGs)
    b) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block
    c) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval
    14. Uncontrolled abnormalities of serum potassium, sodium, calcium (corrected) phosphate or magnesium levels.
    15. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated IMP or previous significant bowel resection that would preclude absorption of Irosustat or the AI.

    *If the patient has discontinued the AI within this period they can be restarted on the same AI. This must be continued for at least 7 days before introducing the IMP. Baseline investigations must be performed in timeframes related to the start of the IMP, not the AI.
    E.5 End points
    E.5.1Primary end point(s)
    Clinical benefit defined as complete response / partial response plus stable disease for at least 6 months (RECIST v1.1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessments will be performed using CT or MRI scans of the chest, abdomen and pelvis. Baseline assessments will be performed no more than 28 days prior to the start of study treatment, and ideally as close as possible to the start of study treatment. Baseline assessments will encompass all areas known to be prone to metastatic spread in breast cancer and will additionally investigate areas that may be involved based on signs and symptoms of individual patients. Any other sites at which new disease is suspected will also be appropriately imaged. Following the baseline assessment, subsequent assessments will be carried out every 3 months.
    E.5.2Secondary end point(s)
    1) Duration of clinical benefit as defined by the number of days from start of study drug to the first evidence of disease progression or death due to any cause (RECIST v1.1).

    2) Objective response rate as defined by complete response and partial response(RECIST v1.1).

    3) Progression free survival is defined as time from randomisation to first evidence of disease progression or death due to any cause (RECIST v1.1).

    4) Safety and tolerability as assessed by the collection of adverse events according to the Common Terminology Criteria for Adverse Events

    5)To measure the alterations in circulating steroid hormones and correlate these measures with clinical outcome.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease assessments for clinical benefit duration, objective response rate and progression free survival will be performed using CT or MRI scans of the chest, abdomen and pelvis. Baseline assessments will be performed no more than 28 days prior to the start of study treatment, and ideally as close as possible to the start of study treatment. Following the baseline assessment, subsequent assessments will be carried out every 3 months.

    Safety and tolerability and alterations in circulating steroid hormones will be assessed by the the collection of adverse events and blood samples at baseline and thereafter monthly for the first 6 months. After the 6 month visit assessments will be carried out every 3 months.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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.7.1.3.1Other 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.4.1Number of sites anticipated in Member State concerned9
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    Last patient's last data capture
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days29
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 19
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state27
    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)
    None, Irosustat is not a marketed drug and as such is not available outside this trial. Following study completion, participating patients will be discharged to standard care and will be treated according to local practise.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Not applicable
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-12-17
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