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    Summary
    EudraCT Number:2010-021091-28
    Sponsor's Protocol Code Number:AB10004
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prohibited by CA
    Date on which this record was first entered in the EudraCT database:2015-02-05
    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 number2010-021091-28
    A.3Full title of the trial
    A multicenter, randomised, open-label, three-parallel groups, phase 2-3 study to evaluate the efficacy and safety of masitinib with dexamethasone, gemcitabine with dexamethasone and the combination of masitinib, gemcitabine and dexamethasone in patients with relapsed or refractory peripheral T-cell lymphoma
    Multicentrická, randomizovaná, otvorená štúdia fázy II-III s tromi paralelnými skupinami určená k vyhodnoteniu účinnosti a bezpečnosti masitinibu s dexametazónom, gemictabínu s dexametazónom a kombinácie masitinibu, gemcitabínu a dexametazónu u pacientov so znovu sa objavujúcim či liečbe odolným T-bunkovým lymfómom.


    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare masitinib with dexamethasone and gemcitabine in the treatment of patients with relapsed or refractory peripheral T-cell lymphoma
    Štúdia k porovnaniu masitinibu s dexametazónom a gemcitabínom pri liečbe pacientov so znovu sa objavujúcim alebo liečbe odolným periferálnym T-bunkovým lymfómom
    A.4.1Sponsor's protocol code numberAB10004
    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 pointCécile Artus-Arduise
    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 76 35
    B.5.6E-mailcecile.artus-arduise@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
    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 INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.4EV Substance CodeSUB126308
    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.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
    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 INNmasitinib mesylate
    D.3.9.1CAS number 790-299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.4EV Substance CodeSUB126308
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or refractory Peripheral T-cell lymphoma
    Znovu sa objavujúci alebo liečbe odolný periferálny T-bunkový lymfóm
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory Peripheral T-cell lymphoma
    Znovu sa objavujúci alebo liečbe odolný periferálny T-bunkový lymfóm
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061871
    E.1.2Term Non-Hodgkin's lymphoma transformed recurrent
    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)
    Celkové prežitie (OS)
    E.2.2Secondary objectives of the trial
    • Efficacy:
    o Survival rates at W12, W24 and then every 24 weeks
    o Overall Progression Free Survival (PFS)
    o Progression Free Survival (PFS) rates at W12, W24 and then every 24 weeks
    o Overall Time to Progression (TTP)
    o TTP rate at W12, W24 and then every 24 weeks
    o Response rate at W12, W24 and then every 24 weeks
    o Best response rate during study treatment
    o Duration of response
    o Clinical benefit defined as time to reappearance or progression of lymphoma-related symptoms every 4 weeks until W24 and then every 12 weeks
    o Time to next PTCL treatment
    • Safety profile in each group using the NCI CTCAE v4.03 classification
    • Other analysis:
    o Expression analysis
    o Cytidine Deaminase Activity
    o Pharmacogenomic analysis:
    • Pharmacokinetics study (in group 1)
    • Účinnosť:
    o Miera prežitia v týždni T12, T24 a potom každých 24 týždňov
    o Celkové prežitie bez progresie (PFS)
    o Miera celkového prežitia bez progresie (PFS) v týždni T12, T24 a potom každých 24 týždňov
    o Celková doba do progresie (TTP)
    o Miera celkovej doby do progresie (TTP) v týždni T12, T24 a potom každých 24 týždňov
    o Miera odpovedi v týždni T12, T24 a potom každých 24 týždňov
    o Najlepšia miera odozvy v priebehu študijnej liečby
    o Doba odozvy
    o Klinický prínos definovaný ako čas do znovu objavenia sa alebo progresie príznakov súvisiacich s lymfómom každé 4 týždne do T24 a potom každých 12 týždňov
    o Doba do ďalšej PTCL liečby
    • Bezpečnostný profil každej skupiny za použitia klasifikácie NCI CTCAE v4.03
    • Ďalšie analýzy:
    o Analýza expresie: Expresia c-Kitu, PDGFR, tryptázy, DCK (deoxycytidin kinázy) a ďalších markerov realizovaná na nádorovom tkanive pred študijnou liečbou k vyhodnoteniu spojitosti s účinnosťou a/alebo toxicitou študijnej liečby.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with histologically/cytologically confirmed peripheral T-cell lymphoma (PTCL), using the World Health Organisation (WHO) disease classification 2008:
    • Adult T-cell lymphoma/leukemia (human T-cell leukemia virus [HTLV] 1+)
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic large cell lymphoma ALK+
    • Anaplastic large cell lymphoma ALK-
    • Peripheral T-cell lymphoma - NOS (not otherwise specified)
    • Extranodal Natural Killer (NK)/T-cell lymphoma
    • Enteropathy-associated T-cell lymphoma
    • Hepatosplenic T-cell lymphoma
    • Subcutaneous panniculitis T-cell lymphoma
    • Transformed mycosis fungoides
    2. Patient with documented progression of disease after at least 1 previous chemotherapy cycle
    3. Patient with minimum 1 bidimensionally measurable disease (more than 1.5 cm) according the Cheson criteria
    4. Patient having Ann Arbor stage II–IV
    5. Patient with ECOG Performance Status < 2
    6. Patients with adequate organ function
    • Absolute neutrophils count (ANC) ≥ 1.5 x 109/L, or ≥ 1 x 109/L in case of medullary involvement
    • Haemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 75 x 109/L
    • AST/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 (≤ 3xULN in case of liver metastases)
    • Normal Creatinine or if abnormal creatinine, creatinine clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    • Albumin > 1 x LLN
    • Proteinuria < 30 mg/mL (1+) on the dipstick. If proteinuria is ≥ 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    7. Patient with life expectancy > 3 months
    8. Man or woman, age ≥ 18 years
    9. Body mass index > 18 and body weight > 40 kg
    10. Man and woman of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test) must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake.
    11. Patient able and willing to comply with study procedures as per protocol.
    12. 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.
    13. 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.
    1. Pacienta s histologicky / cytologicky potvrdeným periférnym T-lymfómom (PTCL), podľa klasifikácie Svetovej zdravotníckej organizácie (WHO) 2008:
    • Adult T-bunkový lymfóm / leukémia (ľudské T bunky lymfotropného vírusu [HTLV] 1 +)
    • Angioimunoblastický T-bunkový lymfóm
    • Anaplastický veľko bunkový lymfóm ALK +
    • anaplastický veľko bunkový lymfóm ALK-
    • Periférny T-lymfóm - NOS (nie je uvedené inak)
    • Extranodálny lymfóm z NK / T buniek
    • enteropatia spojená s T-bunkovým lymfómom
    • Hepatosplenický T-bunkový lymfóm
    • Podkožný panniculitis T-bunkového lymfómu
    •Transformované mycosis fungoides
    2. Pacient s dokumentovanou progresiou choroby po aspoň jednom predchádzajúcom cykle chemoterapie
    3. Pacient s minimálne 1 dvojdimenzionálne merateľným ochorením (viac ako 1,5 cm) podľa Cheson kritéria
    4. Pacient s Ann Arbor fáza II-IV
    5. Pacient s ECOG < 2
    6. Pacient s adekvátnou funkciou orgánov:
    • Absolútny počet neutrofilov (ANC) ≥ 1,5 x 109/L alebo ≥ 1 x 109/L v prípade zapojenia drene
    • Hemoglobín ≥ 10 g/dL
    • Doštičky (PTL) ≥ 75 x 109/L
    • AST/ALT ≤ 3x ULN (≤ 5 x ULN v prípade metastáz pečene)
    • Gamma GT ≤ 2.5 x ULN (≤ 5 x ULN v prípade metastáz pečene)
    • Bilirubín ≤ 1,5 x ULN (≤ 3 x ULN v prípade metastáz pečene)
    • Normálna hladina kreatinínu, alebo pokiaľ je abnormálna, klírens kreatinínu ≥ 50 ml/min (Cockcroftov a Gaultov vzorec)
    • Albumín > 1 x LLN
    • Proteinúria < 30mg/ml (1+) na dipsticku. Pokiaľ je protenúria ≥ 1+ na dipsticku, 24 hodinová proteinúria musí byť < 1,5 g/24 hodín
    7. Pacient s očakávanou dĺžkou života > 3 mesiace
    8. Pacienti ženského alebo mužského pohlavia vo veku > 18 rokov
    9. Pacient s BMI > 18 a vážiaci > 40 kg
    10. Pacienti mužského alebo ženského pohlavia v produktívnom veku, (vstup do štúdie po menštruačnom cykle s negatívnym tehotenským testom) musia súhlasiť s 2 metódami (jedna pre pacienta a jedna pre partnera) akceptovateľnej formy antikoncepcie počas štúdie a po 3 mesiace po poslednom užití medikácie.
    11. Pacient schopný a ochotný dodržiavať študijné postupy podľa protokolu
    12. Pacient schopný rozumieť karte pre pacienta a riadiť sa pokynmi na nej v prípade známok alebo symptómov vážnej neutropénie alebo vážnej kožnej toxicity počas prvých 2 mesiacov
    13. Pacient schopný rozumieť, podpísať a datovať písomný informovaný súhlas na screeningovej návšteve pred akýmikoľvek procedúrami špecifikovanými v protokole. Pokiaľ je pacient považovaný ošetrujúcim lekárom za kognitívne poškodeného alebo sporne poškodeného takým spôsobom, že schopnosť pacienta dať informovaný súhlas je sporná, musí byť určený zákonný zástupca, ktorý informovaný súhlas podpíše.
    E.4Principal exclusion criteria
    1. Patient with:
    • T-cell prolymphocytic leukemia
    • T-cell large granular lymphocytic leukemia
    • Mycosis fungoides, other than transformed mycosis fungoides
    • Sezary syndrome
    • Primary cutaneous CD30+ T-cell lymphoproliferative disorders
    2. Patient with central nervous involvement of lymphoma
    3. Patient with previous allogeneic stem cell transplantation
    4. Patient who relapsed less than three months after an autologous stem cell transplantation
    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 (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 clinically uncontrolled infectious diseases and patient with Human Immunodeficiency Virus infection and/or hepatitis B or C infection
    7. Patient with history of any other malignancy within the 5 years prior to study treatment, except carcinoma in situ of the cervix or basal cell carcinoma of the skin
    8. Pregnant or nursing woman
    9. 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
    10. Patient with known hypersensitivity to gemcitabine and/or excipients

    WASHOUT
    • Patient with a major surgery or radiation therapy within four weeks of starting the study treatment
    • Treatments with an investigational agent or anti-tumor therapy (any chemotherapy, radiotherapy, immunotherapy or biologic agent) within 4 weeks prior to baseline
    • Treatment with corticosteroids within 7 days prior to baseline (except prednisone at a maximal dose of 0.5 mg/kg/day for less than 1 month)
    • Patients to be treated with gemcitabine will require a delay of at least four weeks between radiotherapy and the start of their treatment with gemcitabine.
    1. 1. Pacient s:
    • T-bunkovou prolymfocytárnou leukémiou
    • T-bunkovou large granular lymfocytárnou leukémiou
    • mycosis fungoides, inou než transformovanou mycosis fungoides
    • Sezar syndrómom
    • Primárna kožná CD30 + T-bunková lymfoproliferatívna porucha
    2. Pacient s centrálnym nervovým zapojením lymfómu
    3. Pacient s predchádzajúcou alogénnou transplantáciou kmeňových buniek
    4. Pacient s relapsom menej než tri mesiace po autológnej transplantácii kmeňových buniek
    5. Pacienti trpiaci srdcovými chorobami definovanými aspoň jednou z nasledujúcich podmienok:
    • Pacient s nedávnou srdcovou históriou (počas 6 mesiacov):
    o Akútneho koronárneho syndrómu
    o Akútneho srdcového zlyhania (triedy III alebo IV NYHA klasifikácie)
    o Výrazná ventrikulárna arytmia (perzistentná ventrikulárna tachykardia, ventrikulárna fibrilácia, resuscitácia náhlej smrti)
    • Pacient so srdcovým vynechávaním triedy III alebo IV klasifikácie NYHA
    • Pacient so silnými poruchami vedenia, ktoré nezabraňujú stimulácii (atrioventrikulárny blok 2 a 3, sinoatriálny blok)
    • Synkópa bez známej etiológie počas 3 mesiacov
    • Nekontrolovaná silná hypertenzia, podľa uváženia skúšajúceho alebo symptomatická hypertenzia
    6. Pacient s klinicky nekontrolovaným infekčným ochorením a pacient s vírusom HIV a/alebo infekčnou hepatitídou B alebo C
    7. Pacient s anamnézou inej malignity 5 rokov pred zaradením do štúdie, s výnimkou karcinómu krčka maternice in situ, alebo karcinómu bazálnych buniek kože
    8. Tehotná alebo dojčiaca pacientka
    9. Pacient s históriou zlej spolupráce alebo históriou užívania tabliet/alkoholu, alebo nadmernou spotrebou alkoholických nápojov, ktoré by zasahovali do schopnosti vyhovieť študijnému protokolu alebo aktuálne či predchádzajúce psychiatrické ochorenie, ktoré by zasahovalo do schopností vyhovieť študijnému protokolu či dať informovaný súhlas.
    10. Pacient so známou precitlivenosťou na gemcitabín a / alebo pomocné látky

    VYMÝVACIA DOBA
    1. Pacient s rozsiahlym chirurgickým výkonom alebo rádioterapiou počas štyroch týždňov od zahájenia študijnej liečby.
    2. Liečba študijnou liečbou alebo proti nádorovou terapiou (akákoľvek chemoterapia, rádioterapia, imunoterapia a biologické látky) do 4 týždňov pred zaraďovacou návštevou (baseline).
    3. Liečba kortikosteroidmi počas 7 dní pred zaraďovacou návštevou (baseline), (okrem prednizónu v maximálnej dávke 0,5 mg /kg/deň po dobu kratšiu než 1 mesiac).
    4. U pacientov, ktorí budú liečení gemcitabínom, je vyžadovaný odstup aspoň 4 týždne medzi rádioterapiou a začiatkom ich liečby gemcitabínom.
    E.5 End points
    E.5.1Primary end point(s)
    •Overall survival (OS) defined as the time from randomisation to the date of death due to any cause.
    Celkové prežitie (OS) definované ako čas od randomizácie do dátumu zdokumentovanej smrti z akejkoľvek príčiny
    E.5.1.1Timepoint(s) of evaluation of this end point
    the time from randomisation to the date of death
    čas od randomizácie do dátumu úmrtia
    E.5.2Secondary end point(s)
    • Efficacy:
    o Survival rates at W12, W24 and then every 24 weeks
    o Overall Progression Free Survival (PFS)
    o Progression Free Survival (PFS) rates at W12, W24 and then every 24 weeks
    o Overall Time to Progression (TTP)
    o TTP rate at W12, W24 and then every 24 weeks
    o Response rate at W12, W24 and then every 24 weeks
    o Best response rate during study treatment
    o Duration of response
    o Clinical benefit defined as time to reappearance or progression of lymphoma-related symptoms every 4 weeks until W24 and then every 12 weeks
    o Time to next PTCL treatment
    • Safety profile in each group using the NCI CTCAE v4.03 classification
    • Other analysis:
    o Expression analysis: Expression of c-Kit, PDGFR, tryptase, DCK (Deoxycytidine kinase) and other markers realized on tumour tissue before study treatment to evaluate the association with efficacy and/or toxicity of study treatment.
    o Cytidine Deaminase Activity in blood to evaluate the association with efficacy and/or toxicity to study treatment including gemcitabine.
    o Pharmacogenomic analysis: DNA analysis, studying gene amplification, deletion or mutation focused on genes involved in proliferation/survival pathways and genes involved in metabolism of gemcitabine, will be studied on tumor biopsy and/or blood to evaluate association with efficacy and/or toxicity of study treatment.
    • Pharmacokinetics study (in group 1) to evaluate a potential interaction of dexamethasone on masitinib pharmacokinetic parameters.
    • Účinnosť:
    o Miera prežitia v týždni T12, T24 a potom každých 24 týždňov
    o Celkové prežitie bez progresie (PFS)
    o Miera celkového prežitia bez progresie (PFS) v týždni T12, T24 a potom každých 24 týždňov
    o Celková doba do progresie (TTP)
    o Miera celkovej doby do progresie (TTP) v týždni T12, T24 a potom každých 24 týždňov
    o Miera odpovedi v týždni T12, T24 a potom každých 24 týždňov
    o Najlepšia miera odozvy v priebehu študijnej liečby
    o Doba odozvy
    o Klinický prínos definovaný ako čas do znovu objavenia sa alebo progresie príznakov súvisiacich s lymfómom každé 4 týždne do T24 a potom každých 12 týždňov
    o Doba do ďalšej PTCL liečby
    • Bezpečnostný profil každej skupiny za použitia klasifikácie NCI CTCAE v4.03
    • Ďalšie analýzy:
    o Analýza expresie: Expresia c-Kitu, PDGFR, tryptázy, DCK (deoxycytidin kinázy) a ďalších markerov realizovaná na nádorovom tkanive pred študijnou liečbou k vyhodnoteniu spojitosti s účinnosťou a/alebo toxicitou študijnej liečby.
    o Aktivita Cytidin Deaminázy v krvi k vyhodnoteniu spojitosti s účinnosťou a/alebo toxicitou študijnej liečby vrátane gemcitabínu.
    o Farmakogenomická analýza: DNA analýza, štúdium génovej amplifikácie, delécie alebo mutácie so zameraním na gény zapojené do dráh proliferácie/prežitia a génov zapojených do metabolizmu gemcitabínu, budú študované na biopsii nádoru a/alebo krvi k vyhodnoteniu asociácie s účinnosťou a / alebo toxicitou študijnej liečby.
    o Farmakokinetická štúdia (v skupine 1) k zhodnoteniu potenciálnej interakcie dexametazónu na farmakogenomických parametroch masitinibu
    E.5.2.1Timepoint(s) of evaluation of this end point
    see section E.5.2
    viď. sekcia E.5.2
    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 Yes
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Austria
    China
    Czech Republic
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Italy
    Korea, Republic of
    Malaysia
    Philippines
    Romania
    Russian Federation
    Serbia
    Singapore
    Spain
    Taiwan
    Thailand
    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 could be treated until progression.
    Pacienti môžu byť liečení do progresie.
    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 days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 Yes
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 255
    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
    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 Decision2015-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-23
    P. End of Trial
    P.End of Trial StatusProhibited by CA
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