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    Summary
    EudraCT Number:2012-003361-18
    Sponsor's Protocol Code Number:PM0259CA229J1
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-06
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-003361-18
    A.3Full title of the trial
    Phase II trial of oral vinorelbine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) positive mutation after a failure to treatment with EGFR Tyrosine Kinase Inhibitors (TKI) in first line.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial of oral vinorelbine in a population of patients with lung cancer with an EGFR mutation, after failure to treatment with TKI in first line.
    A.4.1Sponsor's protocol code numberPM0259CA229J1
    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 SponsorPIERRE FABRE MEDICAMENT
    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 supportPIERRE FABRE MEDICAMENT
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPIERRE FABRE MEDICAMENT
    B.5.2Functional name of contact pointMarcello RIGGI
    B.5.3 Address:
    B.5.3.1Street Address45 PLACE ABEL GANCE
    B.5.3.2Town/ cityBOULOGNE BILLANCOURT
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number+330149108177
    B.5.5Fax number+330149108328
    B.5.6E-mailmarcello.riggi@pierre-fabre.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 Yes
    D.2.1.1.1Trade name Navelbine® oral/Capsule, soft, 20mg
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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.3.4Pharmaceutical form Capsule, soft
    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 INNVinorelbine tartrate
    D.3.9.1CAS number 125317-39-7
    D.3.9.2Current sponsor codePM0259
    D.3.9.3Other descriptive nameVINORELBINE TARTRATE
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 Yes
    D.2.1.1.1Trade name Navelbine® oral/Capsule, soft, 30mg
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE MEDICAMENT
    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.3.4Pharmaceutical form Capsule, soft
    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 INNVinorelbine tartrate
    D.3.9.1CAS number 125317-39-7
    D.3.9.2Current sponsor codePM0259
    D.3.9.3Other descriptive nameVINORELBINE TARTRATE
    D.3.9.4EV Substance CodeSUB20777
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Patients with:
    -Histologically or cytologically confirmed NSCLC (stage IIIB or IV) and
    -epidermal growth factor receptor (EGFR) positive mutation and
    -previously treated with tyrosine kinase inhibitor (gefitinib or erlotinib)
    E.1.1.1Medical condition in easily understood language
    Patients with lung cancer and epidermal growth factor receptor (EGFR) positive mutation, previously treated with tyrosine kinase inhibitor
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10029515
    E.1.2Term Non-small cell lung cancer 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
    To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor

    E.2.2Secondary objectives of the trial
    To evaluate efficacy and safety parameters :
    The Duration of Disease Control,
    The Objective Response Rate and Duration of Response,
    The Time to First Response,
    Duration of Stable Disease,
    The Progression-Free Survival (PFS),
    Time To Treatment Failure (TTF),
    The Overall Survival (OS),
    The tolerance
    in the setting of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
    - Patients > or = 18 years.
    - Histologically or cytologically confirmed NSCLC.
    - Patients with epidermal growth factor receptor (EGFR) positive mutation.
    - Patients progressing or relapsing after treatment with EGFR tyrosine kinase inhibitors but a minimum of 2 weeks must have elapsed prior to start of study treatment.
    - Performance status KPS > or = 70% (ECOG/WHO PS 0-1).
    - Stage IIIB (with supra-clavicular nodal metastases), stage IV.
    - Life expectancy more than 12 weeks.
    - Adequate bone marrow, hepatic and renal functions:
    Neutrophils > or = 2.0 x 10^9/l, Platelets > or = 100 x 10^9/l, Haemoglobin > or = 10.0 g/dL;
    Total bilirubin < or = 1.5 x ULN (Upper Limit of Normal), Transaminases (ALT, AST) < 2.5 x ULN, Alkaline Phosphatases < 5 x ULN;
    Calculated creatinine clearance > or = 40 ml/min (Cockcroft and Gault formula).
    - Prior therapy:
    Chemotherapy: patient must not have had systemic chemotherapy or
    immunotherapy (monoclonal antibody);
    Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area. A minimum of 2 weeks must have elapsed prior to start of study treatment.
    - Presence of at least one measurable lesion (measured in at least one dimension) which has not been previously irradiated (RECIST criteria – version 1.1). Physical examination and ultrasound will not be considered as objective tumour assessments.
    - Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
    - Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
    - Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment.
    - The patient must have access to social insurance according to local regulations.
    E.4Principal exclusion criteria
    Patients with at least one of the following criteria will not be included:
    - Known hypersensitivity to the study drug or to drugs with similar chemical structures.
    - Participation in another clinical trial with any experimental drug (except approved EGFR-TKIs) within the 30 days before registration and/or during the study.
    - Any important factor likely to modify drug absorption (e.g. surgery of the gastrointestinal tract, significant malabsorption syndrome or disease affecting the gastrointestinal tract function).
    - Previous radiotherapy in the only site used to assess response.
    - Clinically relevant or unstable systemic disease making implementation of the protocol difficult.
    - Active brain metastases except for the followings:
    Asymptomatic brain metastases
    incidentally found during screening process which does not require local treatment in the opinion of the investigator (2nd cohort, postamendment
    PA04).
    Asymptomatic brain metastases for which local treatment has been given: at least 1 week off corticosteroids and/or anticonvulsants treatment before study
    registration (2nd cohort, postamendment PA04).
    - Meningeal carcinomatosis.
    - Symptomatic neuropathy (sensory) > or = grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2).
    - Weight loss > 10% within the previous 3 months.
    - Long term oxygen therapy.
    - Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
    - Women if pregnant or lactating or with positive pregnancy test at inclusion;
    - Women of childbearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment.
    - Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential.
    - Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval > 5 years.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the disease control rate (CR, PR, SD) of oral vinorelbine as
    a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumour assessment will be performed according to the RECIST guideline (version 1.1). Assessment of measurable disease will be carried out at baseline and every 6 weeks until disease progression.
    E.5.2Secondary end point(s)
    To evaluate efficacy and safety parameters
    the objective response rate.
    the duration of the disease control,
    the duration of stable disease
    the duration of response,
    the time to first response,
    the time to Treatment Failure (TTF),
    the Progression Free Survival (PFS),
    the Overall Survival (OS).
    the tolerance in this setting

    of oral vinorelbine as a single agent in patients with lung cancer and a EGFR positive mutation, previously treated with tyrosine kinase inhibitor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 6 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Singapore
    Taiwan
    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
    The end of the study period is defined as the date of last progression observed in the study. Survival information will be collected approximately every 3 months until death.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years3
    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: 37
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 75
    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)
    Described in protocol
    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 Decision2013-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-17
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