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    Summary
    EudraCT Number:2013-003009-24
    Sponsor's Protocol Code Number:F17752GE101QO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-16
    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 number2013-003009-24
    A.3Full title of the trial
    PHASE I-II STUDY OF F17752 IN PATIENTS WITH ADVANCED SOLID TUMOURS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHASE I-II STUDY OF F17752 IN PATIENTS WITH ADVANCED SOLID TUMOURS
    A.4.1Sponsor's protocol code numberF17752GE101QO
    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 pointCLINICAL STUDY MANAGER
    B.5.3 Address:
    B.5.3.1Street Address45 PLACE ABEL GANCE
    B.5.3.2Town/ cityBOULOGNE
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number33149108245
    B.5.5Fax number33149108330
    B.5.6E-mailmaud.brandely@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 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 nameF17752
    D.3.2Product code F17752
    D.3.4Pharmaceutical form Capsule, hard
    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 INNF17752
    D.3.9.2Current sponsor codeF17752
    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.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 advanced solid tumors
    E.1.1.1Medical condition in easily understood language
    patients with advanced solid tumors
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10065147
    E.1.2Term Malignant solid tumor
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: to determine the maximal tolerated dose (MTD) of F17752 administered orally once a day for 2 weeks followed by one week rest every 3 weeks in patients with advanced solid tumors
    Phase II: to evaluate the efficacy of the F17752 in 2 histologically and molecularly defined cohorts of patients in terms of response rate (NSCLC and colon cancer)
    E.2.2Secondary objectives of the trial
    Phase I:
    to determine the recommended dose (RD) of F17752 to be used in the Phase II
    to assess the safety of F17752
    to assess the antitumor activity of F17752
    to assess the pharmacokinetics of F17752 including preliminary investigation of the food effect

    Phase II
    to extand the evaluation of safety at the RD
    to assess the progression free survival and the overall survival
    to asses the the pharmacokinetics of F17752 at the RD
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - A Phase I part testing increasing doses of F17752 in patients with advanced solid tumours
    - A Phase II part investigating the efficacy of F17752 in 2 histologically and molecularly defined cohorts of patients (NSCLC and colon cancer).
    E.3Principal inclusion criteria
    Phase I
    Histologically or cytologically confirmed advanced solid tumour. Patients with solid tumours known to present with Alk, ROS or Trk rearrangement will be preferentially recruited
    Refractory to available therapies or for whom no standard of care therapy is available
    Phase II
    Cohort 1: NSCLC patients whose tumours exhibit Alk or ROS rearrangement and who are resistant to at least one prior Alk inhibitor, or other actionable targets pertinent to F17752 activity,
    Cohort 2: patients with colon cancer whose tumours exhibit Trk rearrangement, or other actionable targets pertinent to F17752 activity.
    Criteria common to phase I and phase II parts
    1. Tumour tissue available for analysis. If sufficient tissue is not available, patients must undergo a biopsy to obtain adequate samples. In cohort 1 for which failure to prior Alk inhibitor is required, tumour tissue must be obtained following failure to prior therapy,
    2. Measurable disease according to RECIST (version 1.1),
    3. Female or male, 18 years of age or older,
    4. WHO performance status <or=1 (Appendix 2),
    5. Anticipated life expectancy > or=12 weeks,
    6. Adequate haematological function defined as ANC > or= 1.5 x 109/L, platelet count > or= 100 x 109/L and haemoglobin > or= 9 g/dL,
    7. Adequate liver function tests defined as total bilirubin <or= Upper Limit of Normal (ULN), AST and ALT <or= 3 x ULN,
    8. Adequate renal function defined as serum creatinine <or= 1.5 x ULN,
    9. Normal QT interval on electrocardiogram performed at baseline
    10.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 minimized. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment,
    11. Fertile men must be using an effective method of birth control throughout the study period and up to 3 months after the last dose of study drug if their partners are women of childbearing potential,
    12. The patient must have access to social insurance if applicable in the local regulations,
    13. Informed written consent,
    14. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
    E.4Principal exclusion criteria
    for Phase I and Phase II
    1. Major surgery, radiotherapy or systemic anti-cancer therapy within 3 weeks of starting study treatment ; only for systemic anticancer therapy, within 2 weeks in cohort 1,
    2. Patients central nervous system metastases unless the patient has completed local therapy, is stable for at least 4 weeks on CT-scan without evidence of cerebral oedema and has no requirement for corticosteroids or anticonvulsivants,
    3. Current active infection; any concurrent, uncontrolled medical disorder, making implementation of the protocol difficult,
    4. Known HIV infection,
    5. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix, and surgically-treated-only or lobular carcinoma in situ of the breast diagnosed more than 5 years ago,
    6. Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmia not controlled by medication or uncontrolled congestive heart failure,
    7. Known malabsorption syndrome or other gastrointestinal illness that could affect oral absorption of F17752,
    8. Concurrent treatment with any other anti-cancer therapy,
    9. Participation in another trial of an investigational agent within 30 days before study entry and during the study,
    10. Known hypersensitivity to drugs with similar chemical structures,
    11. Congenital lactose intolerance,
    12. Pregnant or lactating women, women with positive pregnancy test at inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: to determine the maximal tolerated dose (MTD) of F17752 administered orally once a day for 2 weeks followed by one week rest every 3 weeks in patients with advanced solid tumors
    Phase II: to evaluate the efficacy of the F17752 in 2 histologically and molecularly defined cohorts of patients in terms of response rate (NSCLC and colon cancer)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I
    dose escalation will be stopped once the MTD is reached. the recommended dose will be the dose immediately below the MTD or and intermediate dose level (20% increment below the MTD)
    Phase II
    end of the study
    E.5.2Secondary end point(s)
    Phase I:
    to determine the recommended dose (RD) of F17752 to be used in the Phase II
    to assess the safety of F17752
    to assess the antitumor activity of F17752
    to assess the pharmacokinetics of F17752 including preliminary investigation of the food effect

    Phase II
    to extand the evaluation of safety at the RD
    to assess the progression free survival and the overall survival
    to asses the the pharmacokinetics of F17752 at the RD
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase I
    end of the Phase I study, last patient last visit, 30 days after the last study drug administration
    Phase II
    end of the study, date of the last progression of the treated patients
    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 Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    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
    Phase I
    end of the Phase I study, last patient last visit, 30 days after the last study drug administration
    Phase II
    end of the study, date of the last progression of the treated patients
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 122
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 122
    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 Decision2013-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-10-13
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