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    Summary
    EudraCT Number:2011-002965-39
    Sponsor's Protocol Code Number:RHMCAN0890
    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:2013-03-13
    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 number2011-002965-39
    A.3Full title of the trial
    Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and non-progressive disease after first-line docetaxel therapy: A multicenter randomized double-blind placebo-controlled phase III trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised trial to establish whether giving patients with advanced prostate cancer additional drug (orteronal) therapy immediately following chemotherapy will lengthen the time until their disease progresses and increase their quality of life in comparison to placebo.
    A.3.2Name or abbreviated title of the trial where available
    SAKK08/11
    A.4.1Sponsor's protocol code numberRHMCAN0890
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01658527
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSwiss Group for Clinical Cancer Research (SAKK)
    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 supportMillenium Pharmaceuticals
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportSAKK (Swiss Group for Clinical Cancer Research)
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Southampton Clinical Trials Unit
    B.5.2Functional name of contact pointKelly Cozens
    B.5.3 Address:
    B.5.3.1Street AddressMP 131 Southampton General Hospital, Tremona Road
    B.5.3.2Town/ citySouthampton
    B.5.3.3Post codeSO16 6YD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02380795154
    B.5.5Fax number08447740621
    B.5.6E-mailkc8@soton.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 nameOrteronel
    D.3.4Pharmaceutical form 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 INNOrteronel
    D.3.9.1CAS number 566939-85-3
    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 number100
    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
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Castration Resistant Prostate Cancer
    E.1.1.1Medical condition in easily understood language
    Prostate Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate 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
    The aim of this study is to establish whether or not giving patients the trial drug orteronel (an androgen synthesis blocker) after their disease has been stabilised by chemotherapy (docetaxel), will lengthen the time that they are 'event free' (alive and without evidence of clinical progression of their cancer) in comparison to patients who receive a placebo.
    E.2.2Secondary objectives of the trial
    This study is looking to determine whether patient's taking orteronel will have a greater quality of life and use less pain control medication than those who have the placebo.

    It is looking at the side effects of the study drug. It is also looking at whether those taking the study drug survive longer than those on placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient has given voluntary written informed consent before performance of any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
    • Male patient 18 years or older
    • WHO performance status of ≤2 (see Appendix 3)
    • Adenocarcinoma of the prostate, histologically or cytologically confirmed
    • Castration resistance: tumour progression after orchiectomy or during treatment with GnRH analogues (agonists or antagonists)
    • Metastatic disease, radiographically documented (CT/MRI, bone scan)
    • Total testosterone ≤ 50 ng/dL (≤ 1.7 nmol/L)
    • Non-progressive disease after docetaxel first-line treatment with a cumulative dose ≥ 300mg/m2
    No evidence of progression on imaging according to PCWG2 and modified RECIST 1.1 criteria
    PSA levels not elevated ≥ 25% AND at least 2 ng/mL above the nadir since start of docetaxel treatment
    • Non-surgically castrated patient agrees on ongoing use of GnRH analogues (agonists or antagonists) during the trial
    • Laboratory values as specified below:
    PSA ≥ 2 ng/mL
    Potassium ≥ 3.5 mmol/L
    Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L and platelet count ≥ 100 x 10 9/L
    Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    Total bilirubin ≤ 1.5 x ULN (except for patient with Gilbert’s disease)
    Estimated creatinine clearance using the Cockcroft-Gault formula  40 mL/minute
    • Planned start of trial treatment 3 to 6 weeks after last docetaxel administration
    • Screening calculated ejection fraction of ≥ 50% or normal according to local standard by echocardiogram or by multiple gated acquisition (MUGA) scan.
    • Baseline QL questionnaire completed
    • Patient is able and willing to swallow study drug as whole tablet
    • Patient compliance and geographic proximity allow proper staging and follow-up
    • Patient, even if surgically sterilized (i.e., status post vasectomy)agrees to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agrees to completely abstain from intercourse
    E.4Principal exclusion criteria
    • Prior therapy with aminoglutethimide, ketoconazole, orteronel, abiraterone or other modern CYP17 inhibitors
    • Prior chemotherapy for prostate cancer within 12 months before enrollment except from docetaxel
    • Retreatment with docetaxel after interruption of > 5 weeks
    • Concurrent disease requiring higher doses of corticosteroid than the equivalent of 10 mg prednisone per day
    • Known hypersensitivity to trial drug or hypersensitivity to any of its components
    • Patient has received other investigational drugs within 30 days before enrollment
    • Presence of a small cell component in histological specimen
    • Radiotherapy within the last 2 weeks before expected start of the trial treatment
    • Known history of central nervous system (CNS) or spinal cord metastases
    • Current spinal cord compression
    • Diagnosed or treated for another malignancy within 2 years of registration, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or any in situ malignancies
    • History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade ≥ 3 (NCI CTCAE version 4.0) or thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed
    • New York Heart Association Class III or IV heart failure
    • ECG abnormalities of:
    Q-wave infarction, unless identified ≥ 6 months prior to registration
    QTc interval > 460 msec
    • Uncontrolled hypertension despite appropriate medical therapy (blood pressure (BP) of greater than 160 mmHg systolic AND 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the pretreatment evaluation). Note: patients may be rescreened after adjustment of antihypertensive medications.
    • Likely inability (e.g. due to a psychiatric disorder) to understand information on trial related topics, to give informed consent, to comply with the protocol, to fill in Quality of Life forms and to cooperate fully with the investigator and site personnel
    • Known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel
    • Known active chronic hepatitis B or C, life-threatening illness unrelated to cancer, or any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with participation in this study
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is event free survival. An event is defined as one of the following:
    - death from any cause
    - the presence of radiographic progression AND symptomatic/clinical progression
    - the presence of radiographic progression AND PSA progression
    - the presence of symptomatic/clinical progression AND PSA progression
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will be followed up until such a time as their disease has been determined by a clinician to have progressed or they have died.
    E.5.2Secondary end point(s)
    The secondary endpoints in the trial will assess:
    - Adverse events
    - PSA response (30%, 50%, 90% and best overall response)
    - Duration of PSA response (50%)
    - Time to PSA progression
    - radiographic progression free survival (rPFS)
    - Quality of Life and pain response
    - Overall Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be followed up until death. It is anticipated that all patients will be deceased by 2020.
    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 Yes
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    Placebo controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    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
    Each patient will be followed up at 3 monthly intervals from the end of treatment until death or the medical director of the trial terminates follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 92
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 192
    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)
    Patients will receive the trial drug until such a time as their disease progresses. The drug would provide no additional benefit once progression has occurred. Patients will be treated according to standard NHS guidelines once they are in the follow-up period.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-07-20
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