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    Summary
    EudraCT Number:2010-022793-14
    Sponsor's Protocol Code Number:AB10007
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-022793-14
    A.3Full title of the trial
    A prospective, multicentre, open-label, randomised, uncontrolled, phase 1/2 study to evaluate the efficacy and safety of masitinib in combination with 5-fluorouracil (5-FU) or capecitabine, or masitinib in combination with irinotecan, or masitinib in combination with irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol), as second line chemotherapy in patients with gastric or gastro-oesophageal junction metastatic adenocarcinoma.
    A.4.1Sponsor's protocol code numberAB10007
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.10 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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name Irinotecan/Campto®/Camptosar®
    D.2.1.1.2Name of the Marketing Authorisation holderActavis/Pfizer/Hospira/Sandoz/medac GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameIrinotecan
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRINOTECAN
    D.3.9.1CAS number 97682445
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    gastric or gastro-oesophageal junction metastatic adenocarcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level PT
    E.1.2Classification code 10062878
    E.1.2Term Gastrooesophageal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Progression Free Survival (PFS)
    E.2.2Secondary objectives of the trial
    • Survival
    o Overall survival (OS)
    o Survival rate at week 4, 8, 12, 16, 20, 24
    o PFS rate at week 4, 8, 12, 16, 20, 24
    • Tumour assessment
    o Overall Time to progression (TTP)
    o Objective response rate (CR + PR) at week 4, 8, 12, 16, 20, 24
    o Control disease rate (CR + PR + SD) at week 4, 8, 12, 16, 20, 24
    o Best response during study treatment
    o Time to response
    • Quality of life assessment according to the EORTC QLQ-C30 questionnaire at week 4, 8, 12, 16, 20, 24
    • ECOG Performance Status
    • Safety profile using the NCI CTCAE v4.02 classification
    • Pharmacokinetics
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient with histologically or cytologically advanced-stage, recurrent adenocarcinoma of the stomach or gastro-oesophageal junction (unresectable, and/or metastatic)
    2. Patient has failed to one prior cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to baseline. Failure is defined either by progression of disease or by significant toxicity that precludes further treatment.
    3. Patient has recovered of all acute toxic side effects of prior therapy or surgical procedures to grade ≤ 1 National Cancer Institute-Common Toxicity Criteria (NCI-CTCAE v4.02), except for the laboratory values
    4. Patient is at least 4 weeks from any major surgery (at baseline)
    5. Patient is eligible for a second line treatment with 5-fluorouracil (5-FU) or capecitabine, or irinotecan, or irinotecan, 5-fluorouracil (5-FU) and folinic acid (FOLFIRI protocol)
    6. Patient has at least one untreated target lesion that could be measured in one dimension, according to the Response Evaluation Criteria in Solid Tumors (RECIST).
    7. ECOG Performance status ≤ 2
    8. Patient with Karnofsky Performance Status (KPS) ≥ 70
    9. Patient with adequate organ function:
    • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
    • Haemoglobin ≥ 10 g/dL
    • Platelets (PTL) ≥ 100 x 109/L
    • AST/ALT ≤ 5 x ULN
    • Gamma-GT ≤ 5 x ULN
    • Bilirubin ≤ 3x ULN
    • Creatinin clearance ≥ 50 mL/min (Cockcroft and Gault formula)
    • Albumin > LLN
    • Urea ≤ 2 x ULN
    • Proteinuria < 30 mg/dL; in case of proteinuria ≥ 30 mg/dL on the dipstick, 24 hours proteinuria < 1.5g/24 hours
    10. Male or female ≥ 18 years
    11. Patient with life expectancy ≥ 6 months
    12. Patient weight > 40 kg and BMI > 18
    13. Man and woman who childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), 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.
    14. Patient is able and willing to comply with study visits and procedures as per protocol
    15. Patient is able to understand, sign, and date the written informed consent form at the screening visit prior to any protocol-specific procedures performed
    16. Patient affiliated to a social security regimen
    E.4Principal exclusion criteria
    A patient must not be enrolled if he/she fulfils one of the following exclusion criteria:
    1.Patient intolerant to 5-fluorouracil (5-FU) or capecitabine or irinotecan or FOLFIRI protocol
    2.Patient previously treated with more than one prior systemic regimen for the treatment of gastric cancer including chemotherapy and targeted anticancer therapy (including masitinib and other Tyrosine Kinase inhibitors)
    3.Patient who had systemic chemotherapy within 4 weeks before baseline
    4.Patient who had radiotherapy within 4 weeks before baseline
    5.Patient who had major surgery within 4 weeks before the start of study treatment (laparotomy, line placement is not considered major surgery)
    6.Patient who had have not recovered from prior treatments
    7.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 judgment of the investigator, or symptomatic hypertension
    8.Pregnant or nursing female patient
    9.Patient presenting at least a grade II peripheral neuropathy
    10.Patient with active central nervous system (CNS) metastasis or with history of CNS metastasis
    11.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
    •Previous treatment
    12.Patient treated with any investigational agent within 4 weeks prior baseline
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) is defined as the time from the randomisation to the date of documented progression or any cause of death during the study. Progression will be assessed by CT scan according to Modified-RECIST criteria version 1.1.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last patient last visit

    (Patient could be treated until disease progression, limiting toxicity or consent withdrawal)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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.1.3Elderly (>=65 years) Yes
    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 state57
    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 Decision2010-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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