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    Summary
    EudraCT Number:2013-000491-14
    Sponsor's Protocol Code Number:AB12008
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000491-14
    A.3Full title of the trial
    A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2/3 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.
    A prospective, multicenter, open-label, centrally allocated, active-controlled, phase 2/3 study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced/metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcitabine alone in advanced / metastatic epithelial ovarian cancer patients in second line being refractory to first line platinum treatment or in third line.
    A.3.2Name or abbreviated title of the trial where available
    Study to evaluate the efficacy and safety of masitinib in combination with gemcitabine versus gemcit
    A.4.1Sponsor's protocol code numberAB12008
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB SCIENCES S.A.
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address3 avenue George V
    B.5.3.2Town/ cityParigi
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 6 10641954
    B.5.5Fax number+33 1 47202411
    B.5.6E-mailinna.ivanina@ab-sciences.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 790299-79-5
    D.3.9.2Current sponsor codeAB1010
    D.3.9.3Other descriptive nameMASITINIB
    D.3.9.4EV Substance CodeSUB23366
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Advanced/metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer) in second line being refractory to first line platinum treatment or in third line
    carcinoma ovarico avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic ovarian cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10033158
    E.1.2Term Ovarian epithelial cancer 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 every 6 months
    ¿ Progression Free Survival (PFS)
    ¿ PFS rate week every 8 weeks
    ¿ Time To Progression (TTP)
    ¿ TTP rate every 8 weeks
    ¿ Best response rate during the study,
    ¿ Disease control rate (CR + PR + SD)
    ¿ Tumor biomarkers levels (CA 125)
    ¿ Quality of Life every 8 weeks
    - according to the EORTC QLQ-C30 questionnaire
    - ECOG Performance Status
    - Analgesic intake
    - Pain improvement (VAS)
    ¿ Pharmacogenomic assessment of selected genes
    ¿ Safety profile using the NCI-CTCAE v4.03 classification
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patient, with histologically or cytologically confirmed advanced / metastatic epithelial ovarian cancer (including primary peritoneal and primary fallopian tube cancer) either :
    a. first line platinum-refractory ovarian cancer (progression during first-line platinum-based chemotherapy)
    b. first line platinum-resistant ovarian cancer (relapsing within 6 months after the end of first-line chemotherapy);
    c. candidate to third line treatment (refractory, resistant, or sensitive to 2nd line platinum-based therapy or patients who progressed after other type of chemotherapy in 2nd line).
    2. Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade = 1 Common Toxicity Criteria for Adverse Event (CTCAE v4.03), except for the laboratory values
    3. Patient has at least one target lesion that can be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST)
    4. ECOG Performance status = 2
    5. Patient with adequate organ function
    a. Absolute neutrophils count (ANC) = 1.5 x 109/L
    b. Haemoglobin = 10 g/dl
    c. Platelets (PLT) = 75 x 109/L
    d. AST and ALT = 3 x ULN (= 5 x ULN in case of liver metastases)
    e. Gamma GT = 2.5 x ULN (= 5 x ULN in case of liver metastases)
    f. Bilirubin = 1.5x ULN (= 3xULN in case of liver metastases)
    g. Normal Creatinine or if abnormal creatinine, creatinine clearance = 50 mL/min (Cockcroft and Gault formula)
    h. Albuminaemia > 1 x LLN
    i. Urea = 2 x ULN
    j. Proteinuria < 30 mg/dL (1+) on the dipstick. If proteinuria is = 1+ on the dipstick, 24 hours proteinuria must be < 1.5g/24 hours
    6. Patient with life expectancy > 3 months
    7. Patient weight > 40 kg and BMI > 18 Kg/m2
    8. Female patient = 18 years
    9. Patient with nutritional risk index (NRI) = 83.5, i.e. with no or moderate malnutrition; NRI is calculated as follows: NRI = 1.519 x serum albumin level + 0.417 x (current weight / basic weight) x 100
    - serum albumin in g/L
    - basic weight calculation with Lorentz formula for ideal BW for women: (height - 100) - ((height - 150)/2)
    10. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees 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. Acceptable forms of contraception include:
    • A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository);
    • Documented tubal ligation (female sterilisation). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used;
    • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
    • Any other contraceptive method with a documented failure rate of <1% per year;
    • Abstinence, when this is in line with the preferred and usual lifestyle of the patient.
    11. Patient able and willing to comply with study visits and procedures as per protocol
    12. Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures 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
    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 skin toxicity
    14. Patient affiliated to a social security regimen
    E.4Principal exclusion criteria
    1. Patient intolerant to gemcitabine or having received gemcitabine as a second line therapy
    2. Patient who has not recovered from any significant treatment toxicities prior to baseline (=Grade 2)
    3. Patient presenting with cardiac disorders defined by at least one of the following conditions:
    a) 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)
    b) Patient with cardiac failure class III or IV of the NYHA classification
    c) Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
    d) Syncope without known aetiology within 3 months
    e) Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
    4. Pregnant or nursing female patient
    5. Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
    6. Patient treated for a cancer other than epithelial ovarian cancer within 5 years before enrolment, with the exception of basal cell carcinoma or cervical cancer in situ
    7. 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
    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 death due to any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of documented death
    E.5.2Secondary end point(s)
    ¿ Survival rate is defined as the proportion of patients alive at each time point
    ¿ Overall Progression Free Survival (PFS) is defined as the time from the randomization to the date of documented progression or any cause of death during the study.
    Progression will be assessed by CT scan according to RECIST criteria version 1.1 as defined in Table 5.
    ¿ PFS rate is defined as the proportion of patients without progression or death at each time point
    ¿ Overall Time To Progression (TTP) is defined as the time from the randomization to the date of documented progression defined according to RECIST criteria version 1.1
    ¿ TTP rate is defined as the proportion of patients without progression at each time point
    ¿ Best response is defined as best response across all time points during treatment period.
    ¿ Disease control rate (CRR ) is calculated as the number of patients with documented partial response, complete response or stable disease (CR + PR + SD) defined according to RECIST criteria version 1.1, divided by the number of patients allocated at each time point.
    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 No
    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) 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 Yes
    E.8.1.7.1Other trial design description
    seamless adaptive phase 2/3
    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.8.2.3.1Comparator description
    Gemcitabine
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years4
    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 years4
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state
    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 Decision2016-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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