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    The EU Clinical Trials Register currently displays   37205   clinical trials with a EudraCT protocol, of which   6122   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-005696-93
    Sponsor's Protocol Code Number:ACT14205
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-02-04
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005696-93
    A.3Full title of the trial
    Phase II, Open Label, Single Arm Study Assessing the Clinical Benefit of SAR125844, Administered as Single Agent by Weekly Intravenous (IV) Infusion, for the Treatment of Patients with Advanced Pretreated Non-Small Cell Lung Cancer (NSCLC) Harboring MET Gene Amplification
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients with MET Amplification
    A.4.1Sponsor's protocol code numberACT14205
    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 SponsorSanofi-aventis recherche & développement
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Belgium
    B.5.2Functional name of contact pointBrigitte De Witte
    B.5.3 Address:
    B.5.3.1Street AddressAirport Plaza - Montreal Building, L. Da Vincilaan 19
    B.5.3.2Town/ cityDiegem
    B.5.3.3Post code1831
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)2 710 56 18
    B.5.5Fax number+32(0)2 710 56 99
    B.5.6E-mailcontact.us@sanofi.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.3.2Product code SAR125844
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1116743-46-4
    D.3.9.2Current sponsor codeSAR125844
    D.3.9.4EV Substance CodeSUB88508
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Neoplasm malignant
    E.1.1.1Medical condition in easily understood language
    Neoplasm malignant
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10028997
    E.1.2Term Neoplasm malignant
    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
    To determine objective response rate (ORR).
    E.2.2Secondary objectives of the trial
    To assess duration of response (DR), progression free survival (PFS) and overall survival (OS).
    To evaluate global safety profile.
    To determine pharmacokinetic profile.
    To assess clinical utility of fluorescence in situ hybridization (FISH) assay in selection of patients with mesenchymal-epithelial hybridization (MET) gene amplifcation.
    To assess lung cancer symptoms, health-related quality of life and treatment satisfaction.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Metastatic non-small-cell lung cancer patients with progressive disease during or after first or second line therapy harboring MET gene amplification and with measurable disease by
    Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
    E.4Principal exclusion criteria
    Patient less than 18 years old.
    Eastern Cooperative Oncology Group (ECOG) performance status >2.
    More than 2 episodes of disease progression under anticancer therapy.
    Wash out period of less than 3 weeks from prior treatment with chemotherapy, radiotherapy or, surgery or any investigational treatment.
    Adequate hematologic, hepatic, renal, coagulation, and metabolic functions.
    No resolution of any specific toxicities (excluding alopecia) related to any prior anti-cancer therapy to grade ≤1 according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.
    Pregnant or breast-feeding women.
    Patient with reproductive potential without method of contraception.
    Symptomatic brain metastasis.
    Any clinically significant medical condition other than cancer which could interfere with the safe delivery of study treatment or risk of toxicity.
    Known hypersensitivity or any adverse event related to the study drug excipient (Captisol®).
    Prior treatment with any MET Tyrosine Kinase Inhibitors (TKIs) or anti-MET antibodies (excluding onartuzumab).
    Patients treated with potent CYP3A inhibitor unless it can be discontinued.
    Patients treated with potent and moderate CYP3A inducers unless it can be discontinued.
    Mean QTc interval prolongation >470 msec.
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the objective response rate of SAR125844 as per RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks up to disease progression
    E.5.2Secondary end point(s)
    Progression-free survival rate
    Overall survival rate

    Proportion of patients with adverse events

    Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
    Assessment of pharmacokinetic parameters: area under curve (AUC)
    Assessment of pharmacokinetic parameters: total clearance (CL)
    Assessment of pharmacokinetic parameters: half-life (t1/2)

    Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
    Assessment of health-related quality of life by QLQ-C30/LC13

    Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire



    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 34 months
    Progression-free survival rate
    Overall survival rate

    Up to 40 months
    Proportion of patients with adverse events

    Up to 3 days
    Assessment of pharmacokinetic parameters: maximum plasma concentration (Cmax)
    Assessment of pharmacokinetic parameters: area under curve (AUC)
    Assessment of pharmacokinetic parameters: total clearance (CL)
    Assessment of pharmacokinetic parameters: half-life (t1/2)

    Every 3 weeks up to 34 months
    Assessment of lung cancer symptoms by Core Quality of Life questionnaire (QLQ-C30) +LC13
    Assessment of health-related quality of life by QLQ-C30/LC13

    Every 6 weeks up to 34 months
    Assessment of treatment satisfaction by Cancer Therapy Satisfaction Questionnaire



    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Lung Cancer symptoms, health-related quality of life, and treatment satisfaction
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 EEA48
    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
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Turkey
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    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: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 state3
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 168
    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 Decision2015-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-01-05
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