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    Summary
    EudraCT Number:2013-002293-41
    Sponsor's Protocol Code Number:AB12005
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2014-02-19
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2013-002293-41
    A.3Full title of the trial
    A prospective, multicenter, double-randomised, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri.3 versus placebo in combination with Folfiri.3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer.
    Prospektívna, multicentrická, dvojito randomizovaná, dvojito zaslepená štúdia fázy III s dvomi paralelnými skupinami, porovnávajúca účinnosť a bezpečnosť masitinibu v prvej línii liečby v kombinácii s gemcitabínom oproti gemcitabínu v kombinácii s placebom, nasledovaná druhou líniou liečby masitinibom v kombinácii s FOLFIRI 3 oproti placebu v kombinácii s FOLFIRI 3 v liečbe pacientov s neresekovateľným, lokálne rozvinutým alebo metastatickým karcinómom slinivky brušnej.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate 2 types of treatment as first line treatment (masitinib + gemcitabine or placebo + gemcitabine ) and 2 types of treatment as second line treatment (masitinib + FOLFIRI 3 or placebo + FOLFIRI 3) in the treatment of patients with with non resectable locally advanced or metastatic pancreatic cancer.
    Štúdie na hodnotenie 2 druhov liečby v prvej línii liečby (masitinib + gemcitabín alebo placebo plus gemcitabín +) a 2 druhov liečby v druhej línii liečby (masitinib + FOLFIRI 3 alebo placebo + FOLFIRI 3) v liečbe pacientov s neodstrániteľný lokálne pokročilým alebo metastatickým karcinómom slinivky brušnej.
    A.4.1Sponsor's protocol code numberAB12005
    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 pointElena Carmen RADU
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 47 20 30 07
    B.5.5Fax number+331 47 20 24 11
    B.5.6E-mailelena.radu@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 namemasitinib 100mg
    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.3.11 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) Yes
    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.IMP: 2
    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 namemasitinib 200mg
    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.3.11 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) Yes
    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
    Non resectable locally advanced or metastatic pancreatic cancer after
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic pancreatic 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 10033610
    E.1.2Term Pancreatic carcinoma metastatic
    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
    Overall survival (OS)
    E.2.2Secondary objectives of the trial
    • Survival rate is defined as the rate of patients alive at each time point
    • Overall Progression-Free Survival (PFS) is defined as the delay between the date of randomization to the date of documented progression or any cause of death during the study.
    • PFS rate is defined as the rate of patients without progression or death at each time point. Progression is assessed by CT scan.
    • Overall Time To Progression (TTP) is defined as the time from the date of randomization to the date of documented progression
    • TTP rate is defined as the rate of patients without documented progression .
    • Best response is defined as the best response from baseline (CR or PR or SD or PD) assessed by CT scan.
    • Best Response rate is defined as the number of patients achieving the Best Response divided by the total number of patients in the population of analysis.
    • Change in percentage and in absolute value for the level of serum CA 19-9 between baseline and at each time point.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic (DNA) and management of potential risk analysis
    E.3Principal inclusion criteria
    First randomisation inclusion criteria:
    1. Histologically or cytologically confirmed adenocarcinoma of the pancreas
    2. Patient with pain related to the disease, as assessed by the investigator and the patient:
    - Pain related to the disease as assessed by the investigator is defined as clinical and documented evaluation by the investigator during physical examinations at screening and/or baseline.
    - Pain, as assessed by the patient is defined as at least one value out of two values > 5mm on Visual Analogic Scale at screening or baseline. Visual Analogic scale consists in the visual representation of pain amplitude as perceived by the patient. The amplitude is represented by a 100 mm long line having no reference marks. One extremity indicates an absence of pain (0 value) and the other the worst imaginable pain (100 value).
    OR
    Patient treated with opioid analgesics at a dose ≥ 1 mg/kg/day (morphinic equivalent).
    OR
    Patients with ‘genetic fingerprint of aggressiveness’:
    3. Chemotherapy naïve patient for the advanced/metastatic disease
    4. Documented decision justifying non eligibility for surgical resection.
    5. Patient with measurable tumor lesions with longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm with spiral CT scan according to RECIST 1.1
    6. Patient with ECOG ≤ 1
    7. Patient with adequate organ functions:
    • Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
    • Haemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 75 x 109/L
    • AST/ALT ≤ 5 x ULN
    • Gamma GT ≤ 5 x ULN
    • Bilirubin ≤ 3 x ULN
    • Normal Creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    • Albumin > 1x LLN
    • Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    • Patient with life expectancy > 3 months
    8. Male or female patient, age 18 years
    9. Patient with a BMI > 18 kg/m² and >40 kg
    10. Male patient and female patient of childbearing potential must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception (with failure rate < 1%) during the study and for 3 months after the last treatment intake.
    11. Female patient of childbearing potential must agree to have a negative pregnancy test at screening and baseline.
    12. Patient able and willing to comply with study procedures as per protocol
    13. 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 during the first 2 months of treatment.
    14. 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.
    Second randomisation inclusion criteria:
    1. Patient under disease progression (according to RECIST 1.1 or investigator claim) after first line treatment with masitinib in combination with gemcitabine
    OR
    Patient not under disease progression but who discontinued First line treatment for any adverse event not defined as a severe adverse event (grade ≥ 3) due to the mechanism of action of masitinib (i.e. rash, nausea, vomiting or diarrhea).
    2. Patient with adequate organ functions:
    • Absolute neutrophils count (ANC) ≥ 1.5 x 109/L
    • Haemoglobin ≥ 9 g/dL
    • Platelets (PTL) ≥ 75 x 109/L
    • AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases)
    • Gamma GT ≤ 3 x ULN (≤ 5 x ULN in case of liver metastases)
    • Bilirubin ≤ 1.5 x ULN (≤ 3xULN in case of liver metastases)
    • Normal Creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    • Albumin > 1x LLN
    • Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    E.4Principal exclusion criteria
    First randomisation exclusion criteria:
    1. Patient treated for a cancer other than pancreatic cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
    2. Patient with no pain related to the disease (as defined in the inclusion criterion number 2) and no genetic fingerprint of aggressiveness
    3. Patient with ECOG ≥ 2
    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:
    - Acute coronary syndrome
    - Acute heart failure (class III or IV of the NYHA classification)
    - 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 (atrio-ventricular 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 history of poor compliance or 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. Pregnant, intent to be pregnant, or nursing female patient
    Second randomisation exclusion criteria:
    1. Patient intolerant to masitinib
    The patient is considered as intolerant to masitinib if he/she presented with a severe adverse event (grade ≥ 3) due to the mechanism of action of masitinib (i.e. rash, nausea, vomiting or diarrhea) which led to interruption and/or dose reduction of first line treatment followed by a re-challenge of first line treatment leading to the same severe adverse event.
    2. Patient having presented with disabling or life-threatening adverse event due to first line treatment
    E.5 End points
    E.5.1Primary end point(s)
    • Overall Survival (OS) is defined as the time from the randomization to the date of documented death
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of documented death
    E.5.2Secondary end point(s)
    Progression Free Survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 8 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 Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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, 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 treated until disease progression limiting toxicity or consent withdrawal. Follow-up performed 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.2.1Number of subjects for this age range: 449
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    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 Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 549
    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 of care
    Thérapeutique Habituelle de Soins
    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 Decision2014-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-03
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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