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    Summary
    EudraCT Number:2013-000809-23
    Sponsor's Protocol Code Number:AB12003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-08-18
    Trial 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 number2013-000809-23
    A.3Full title of the trial
    A prospective, multicenter, randomized, double blind, placebo-controlled, 2-parallel groups, phase 3 study to compare the efficacy and safety of masitinib in combination with docetaxel to placebo in combination with docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison study to look at the safety and effectiveness of a new drug (masitinib) for treating a prostrate cancer which can spread and which is not easily to be removed against a currently used treatment (docetaxel & prednisone).
    A.3.2Name or abbreviated title of the trial where available
    Phase 3 Masitinib/Placebo + Docetaxel in Metastatic Prostate Cancer V1
    A.4.1Sponsor's protocol code numberAB12003
    A.5.4Other Identifiers
    Name:Investigational New Drug (IND) Number:116620
    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 SponsorAB Science
    B.1.3.4CountryFrance
    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 supportAB Science
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB Science
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressAB Science, 3 Avenue George V
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33147206676
    B.5.5Fax number+33 147 20 24 11
    B.5.6E-mailshoma.das@ab-science.com
    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 nameMastinib mesylate
    D.3.2Product code AB1010
    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 INNMastinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number119.3 to 238.5
    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 placeboFilm-coated tablet
    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
    Castrate Resistant Prostate Cancer (mCRPC)
    E.1.1.1Medical condition in easily understood language
    Modification of some prostate cells that turn into cancer cells and have spread to other organs and cannot be easily removed.

    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 objective is to demonstrate efficacy and evaluate safety of masitinib in combination with docetaxel and prednisone to placebo in combination with docetaxel and prednisone in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).

    The primary endpoint is Progression Free Survival (PFS)
    E.2.2Secondary objectives of the trial
    The objective is to compare the efficacy (overall survival), the safety and the quality of life of masitinib at 6mg/Kg/day in combination with standard docetaxel to matching placebo in combination with standard therapy docetaxel in first line metastatic Castrate Resistant Prostate Cancer (mCRPC).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    During this study, an ancillary pharmacogenomic study will be
    performed in order to confirm or define predictive criteria of overall
    survival from genomic data. An ancillary study aimed at finding potential DNA mutations, amplification and/or deletion that might explain short or long term survival, side effects and treatment response. Tumour biopsies of subjects willing to participate in this sub study will be collected at baseline.

    In addition if a patient experiences severe neutropenia or skin toxicity a blood sample will be taken for analysis to correlate genomic data with the occurrence of these reactions.
    E.3Principal inclusion criteria
    1. Patient aged ≥ 18 years old, with histologically or cytologically confirmed metastatic Castrate Resistant Prostate Cancer (medical or surgical castration: androgens deprivation by GnHR agonist or antagonist or patient with surgical castration; hormonal castration confirmed biologically (testosterone < 0.5ng/ml) with one of the following criteria:
    - Pre-treated with abiraterone with progressed disease documented, OR
    - with indication for initiating docetaxel administration (e.g., widespread visceral disease or rapidly progressive disease).
    - *If surgical castration is done than there will be no requirement to perform testosterone test.
    2. Patient with evidence of progressive metastatic disease. Disease progression at trial enrolment is based on progression in at least one variable described in Table 4
    3. Patient with ECOG ≤ 1
    4. Patient with adequate organ function:
    - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    - Haemoglobin ≥ 10 g/dL
    - Platelets (PTL) ≥ 75 x 109/L
    - AST and ALT ≤ 3x ULN ((≤5 x ULN in case of liver metastases)
    - Gamma GT ≤2.5 x ULN (≤5 x ULN in case of liver metastases)
    - Bilirubin ≤ 1.5x ULN (≤ 3 x ULN in case of liver metastasis)
    - Normal creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    - Albuminaemia > 1 x LLN
    - Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria ≥ 1+ on the dipstick, 24 hours proteinuria must be ≤ 1.5g/24h
    5. Patient with life expectancy > 6 months
    6. Patient with BMI > 18 kg/m2 and weight > 40 kg
    7. Contraception
     Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.
     Highly effective methods of contraception include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
    - Intrauterine device (IUD)
    - Intrauterine hormone-releasing system (IUS)
    - Bilateral tubal occlusion
    - Vasectomized male (azoospermia assessed medically)
    - Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
     Acceptable methods of contraception include:
    - Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    - Male or female condom with or without spermicide
    - Cap, diaphragm, or sponge with spermicide
    8. Patient able and willing to comply with study procedures as per protocol
    9. Patient able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures are performed. If the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable, the designated legal guardian must sign the informed consent.
    10. Patient able to understand the patient card and to follow the patient card procedures in case of signs or symptoms of severe neutropenia or severe cutaneous toxicity.
    E.4Principal exclusion criteria
    1. Patient who has been previously treated with chemotherapy.
    2. Patient with bone marrow irradiation > 40% within 12 months before baseline
    3. Patient treated for a cancer other than prostate cancer within 3 years before enrolment, with the exception of basal cell carcinoma (and pTa or pT1)
    4. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
    5. Patient presenting with cardiac disorders defined by at least one of the following conditions:
    - Patient with recent cardiac history (within 6 months) of:
    o Acute coronary syndrome
    o Acute heart failure (class III or IV of the NYHA classification)
    o Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular
    fibrillation, resuscitated sudden death)
    - Patient with cardiac failure class III or IV of the NYHA classification
    - Patient with severe conduction disorders which are not prevented by permanent pacing (atrioventricular block 2 and 3, sino-atrial block)
    - Syncope without known aetiology within 3 months
    - Uncontrolled severe hypertension, according to the judgement of the investigator, or symptomatic hypertension
    6. Patient with an history of poor compliance or an history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent
    7. Patient under treatment with any anti-tumour therapy (any radiotherapy, chemotherapy, biologic or anti-androgen therapy except GnRH/LHRH analogs)

    WASH OUT
    • Known hypersensitivity to masitinib or to any of the excipients
    • Patients with any investigational agent within 4 weeks prior to baseline
    • Patients with an active infection requiring antibiotics within 14 days prior to baseline
    • Four weeks prior to baseline for anti-androgens (example. bicalutamide) and 5-alpha reductase inhibitors
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 12 weeks.
    E.5.2Secondary end point(s)
    - Key Secondary endpoint - overall Survival (OS)
    - PFS rate at 6,9,12 months based on Kaplan-Meier estimate of PFS distribution
    - OS rate at 12,15,18 months based on Kaplan-Meier estimate of OS distribution
    - Time To Progression (TTP)
    - TTP rate every 12 weeks
    - Best response rate, Objective Response rate: Complete Response (CR) or Partial Response (PR) and disease control rate (CR+ PR+ SD) every 12 weeks
    - Decline of PSA level ≥ 30% from baseline at 12 weeks or later
    - Quality of life assessment every 6 weeks Quality of Life according to the EORTC QLQ-C30 questionnaire
    - Present Pain Intensity score based on the McGill-Melzack Pain Questionnaire (MPQ)
    - Analgesic intake
    - ECOG Performance Status
    - Pain improvement (VAS)
    - Pharmacogenomic assessment: Relationship between genomic data and overall survival.
    - Safety profile using the NCI CTCAE v4.03 classification


    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 12 weeks.
    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 Yes
    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 Yes
    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 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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA100
    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
    Argentina
    Austria
    Belgium
    Brazil
    Canada
    China
    Czech Republic
    Greece
    Hong Kong
    Hungary
    India
    Italy
    Korea, Democratic People's Republic of
    Malaysia
    Mexico
    Morocco
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Singapore
    South Africa
    Spain
    Tunisia
    Ukraine
    United Kingdom
    United States
    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
    Patient is treated until disease progression, limiting toxicity or consent withdrawal. Follow-up preformed until patient's death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days31
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 320
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 580
    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)
    In case of progressive disease with a clinical benefit assessed by the investigator, patients will have the possibility to continue the study medication(masitinib/matching placebo) until withdrawal of consent, investigator decision, intolerance or death.

    If a patient leaves the trial at any time they will be treated according to the standard of care available to them.
    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 South West London Cancer Research Network
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-21
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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