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    Summary
    EudraCT Number:2015-002911-13
    Sponsor's Protocol Code Number:RB15.098
    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:2015-08-05
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-002911-13
    A.3Full title of the trial
    A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 36 CF patients (24 treated, 12 controls).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis.
    A.3.2Name or abbreviated title of the trial where available
    ROSCO-CF
    A.4.1Sponsor's protocol code numberRB15.098
    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 SponsorCHRU de Brest
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPHRC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointFlorence MORVAN
    B.5.3 Address:
    B.5.3.1Street Address2, avenue Foch
    B.5.3.2Town/ cityBREST
    B.5.3.3Post code29609
    B.5.3.4CountryFrance
    B.5.4Telephone number00+33298223319
    B.5.5Fax number00+33298223183
    B.5.6E-mailflorence.morvan@chu-brest.fr
    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.2.1.2Country 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 nameSELICICLIB
    D.3.2Product code CYC202
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis treated by 'roscovitine'
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the safety of increasing doses of roscovitine administered orally for 4 cycles of 4 consecutive days (treatment “on”) separated by a 3 days treatment free period (treatment “off”) in adult CF subjects who are homozygous for F508del mutation.
    E.2.2Secondary objectives of the trial
    – To assess microbiological levels of infection by Pseudomonas aeruginosa;
    – To assess pharmacokinetics of roscovitine and its M3 metabolite and pharmacodynamics;
    – To assess the levels of pro- and anti- inflammatory cytokines some of which are known to be modified by roscovitine;
    – To assess roscovitine target engagement by measurement of the expression level of Mcl-1, a survival factor expressed in neutrophils, the degradation of which is triggered by roscovitine, leading to apoptotic cell death.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients eligible for inclusion in this study have to fulfill all of the following criteria:
    – Male or female aged over 18 years of age on the date of informed consent
    – Diagnosed CF patients. Confirmed diagnosis of CF is defined as (Rosenstein and Cutting, 1998):
    o A sweat chloride value > or = 60 mmol/L by quantitative pilocarpine iontophoresis OR 2 CF-causing mutations
    o AND chronic sinopulmonary disease OR gastrointestinal/nutritional abnormalities
    – Homozygous for the F508del-CFTR mutation, genotype to be confirmed at screening;
    – Positive sweat test (sweat chloride > or = 60 mmol/L) at screening;
    – Forced expiratory volume at 1 second (FEV1) > or = 40% of normal predicted values for age, sex and height based on the Knudson equation;
    – FEV1 at Day 1 must be within 15% of FEV1 at Screening. If FEV1 at Day 1 is not within 15% of FEV1 at Screening, Visit 2 can be repeated within 7 days and rescheduled once;
    – Chronic lung Pseudomonas aeruginosa infection according to the definition from the French Consensus Conference as recommended by the Committee for Medicinal Products for Human use (CMPH) of the European Medicines Agency (EMA).Clinically stable CF disease in the opinion of the investigator;
    – Able to understand and comply with all protocol requirements, restrictions and instructions and likely to complete the study as planned (as judged by the investigator);
    – Provide written informed consent prior to the performance of any study-related procedure;
    – Be affiliated to health insurance;
    – Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
    – Acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before V2
    – Recent patient reported history of
    o non recovered viral upper respiratory tract infection
    o solid organ or hematological transplantation
    – Undergone major surgery within 1 month prior to screening
    – Currently treated allergic broncho-pulmonary aspergillosis (ABPA)
    – Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
    – Hemoptysis more than 60 mL at any time within 4 weeks prior to first study drug administration (V2)
    – History of any other comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
    – Any other clinically significant conditions (not associated with the study indication) at Screening (V1) which might interfere with the assessment of this study
    – Any of the following abnormal laboratory values at screening:
    o Hemoglobin <10 g/dL
    o Abnormal liver function defined as any 3 or more of the following:
    > or = 3 x upper limit of normal (ULN) aspartate aminotransferase (AST)
    > or = 3 x ULN alanine aminotransferase (ALT)
    > or = 3 x ULN gamma-glutamyl transpeptidase
    > or = 3 x ULN alkaline phosphatase
    Or > or = 2 x ULN total biliburin
    o Serum K+ <3,5 mmol/L
    o Abnormal renal function defined as a creatinine clearance <50 mL/min/m2 / glomerular filtration rate < or = 50 mL/min/1,73 m2 (calculated by the Modification of Diet in Renal Disease Study Equation) (Levey et al, 1999, 2006)
    – Any clinically significant laboratory abnormalities (not associated with the study indication) at screening that would interfere with the study assessment or pose an undue risk for the subject (as judged by the investigator)
    – Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by:
    o Congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry
    o A 12- lead ECG at screening demonstrating QTcF>450 or showing clinically significant abnormality including prolonged QT. If the QTcF exceeds 450 msec for the screening ECG, the ECG should be repeated 2 more times during the screening period, and the average of the 3 QTcF values should be used to determine the subject’s eligibility.
    o History of syncope or family history of idiopathic sudden death
    o Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
    – Concomitant disease(s) that could prolong the QT interval.
    – Patients with a history of alcohol or drug abuse in the past year, including but not limited to tobacco, cannabis, cocaine, and opiates as deemed by investigator
    – Patients with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
    – Use of one (or several) prohibited medications and/or food within 30 days prior to Screening (V1)
    – Administration of any investigational drug within 30 days prior to Screening (V1) or 5 half-lives, whichever is longer
    – Use of systemic anti-pseudomonal antibiotics within 28 days prior to first study drug administration (V2). However use of inhaled anti-pseudomonal antibiotic treatment is allowed if initiated for more than 28 days.
    – Use of loop diuretics within 7 days prior to first study drug administration (V2)
    – Pregnant or nursing females: females of childbearing potential must have a negative pregnancy test at screening
    – Sexually active subjects of reproductive potential who are not willing to follow the contraception requirement
    E.5 End points
    E.5.1Primary end point(s)
    Safety, and tolerability of roscovitine vs. placebo, measured by incidence and severity of treatment-emergent adverse events, clinical laboratory values (serum chemistry, hematocrit, Blood Cells Count (BCC), electrolytes, and urinalysis), 12-lead ECG outcomes, vital signs at each visit and until D56.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primaru end points are evaluate at each visit and until D56.
    E.5.2Secondary end point(s)
    – To assess microbiological levels of infection by Pseudomonas aeruginosa and mycobacter;
    – To assess pharmacokinetics of roscovitine and its M3 metabolite and pharmacodynamics;
    – To assess the levels of pro- and anti- inflammatory cytokines some of which are known to be modified by roscovitine;
    – To assess roscovitine target engagement by measurement of the expression level of Mcl-1, a survival factor expressed in neutrophils, the degradation of which is triggered by roscovitine, leading to apoptotic cell death.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    dose ranging
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    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 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
    LVLS
    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 months2
    E.8.9.1In the Member State concerned days
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 No
    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 state36
    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 Decision2015-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-07-26
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