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    Summary
    EudraCT Number:2018-004234-15
    Sponsor's Protocol Code Number:CLEE011A2207
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-004234-15
    A.3Full title of the trial
    A phase II, multicenter, randomized, open-label study to evaluate the safety and efficacy of 400 mg of ribociclib in combination with non-steroidal aromatase inhibitors for the treatment of pre- and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who received no prior therapy for advanced disease.
    II. fázisú, többközpontú, randomizált, nyílt elrendezésű vizsgálat a nemszteroid aromatázgátlóval kombinált 400 mg ribociklib biztonságosságának és hatásosságának értékelésére hormonreceptor-pozitív, HER2-negatív, előrehaladott emlődaganatban szenvedő, menopausa előtti és utáni életszakaszban lévő nőknél, akik korábban még nem kaptak kezelést előrehaladott betegségükre
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the safety and efficacy of ribociclib 400mg in combination with endocrine therapy for the treatment of pre- and postmenopausal women with HR+, HER2- advanced breast cancer who received no previous therapy for advanced disease.
    A.4.1Sponsor's protocol code numberCLEE011A2207
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03822468
    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 SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Hungary Kft.
    B.5.2Functional name of contact pointPublic Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressBartók Béla út 43-47
    B.5.3.2Town/ cityBudapest
    B.5.3.3Post code1114
    B.5.3.4CountryHungary
    B.5.4Telephone number00 36 1 457-6500
    B.5.5Fax number00 36 1 457-6500
    B.5.6E-mailinfoph.hungary@novartis.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 Kisqali
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameribociclib
    D.3.2Product code LEE011
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNRIBOCICLIB
    D.3.9.1CAS number 1374639-75-4
    D.3.9.2Current sponsor codeLEE011
    D.3.9.4EV Substance CodeSUB180246
    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) 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
    HR-positive, HER2-negative advanced breast cancer
    E.1.1.1Medical condition in easily understood language
    advanced breast cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10072737
    E.1.2Term Advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10073289
    E.1.2Term Premenopausal breast cancer
    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
    The primary objective of this study is to determine whether the overall response rate (ORR) in the experimental arm (400 mg) is non-inferior to the control arm (600 mg) based on local tumor assessments (RECIST version1.1) for all patients that have been treated for at least 6 months or have discontinued the study treatment.
    E.2.2Secondary objectives of the trial
    Key secondary objective is to evaluate QTc (with Fridericia's correction) prolongation in the experimental arm.
    Other secondary objectives include safety and tolerability, progression-free survival, clinical benefit rate, time to response, duration of response, pharmacokinetics of ribociclib when given in combination with NSAI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient has advanced (loco-regionally recurrent or
    metastatic) breast cancer not amenable to curative
    therapy.
    -Patient has a histologically and/or cytologically
    confirmed diagnosis of ER-positive and/or PgRpositive
    breast cancer based on the most recently
    analyzed tissue sample, and all tested by local
    laboratory.
    -Patient has HER2-negative breast cancer defined as
    a negative in situ hybridization test or an IHC status of
    0, 1+ or 2+. If IHC is 2+, a negative in situ
    hybridization (FISH, CISH, or SISH) test is required by
    local laboratory testing and based on the most
    recently analyzed tissue sample.
    -Patient must have measurable disease, i.e., at least
    one measurable lesion according to RECIST version
    1.1. (a lesion in a previously irradiated site may only
    be counted as a target lesion if there is clear evidence
    of progression since the irradiation).
    -Patient has an Eastern Cooperative Oncology Group
    (ECOG)
    performance status 0 or 1.
    -Standard 12-lead ECG values defined as the mean of
    the triplicate ECGs and assessed by the central
    laboratory:
    QTc interval at screening < 450 ms (using Fridericia’s
    correction)
    Mean resting heart rate 50 to 90 bpm (determined
    from the ECG)
    -Women of childbearing potential (CBP), defined as all
    women
    physiologically capable of becoming pregnant, must
    have confirmed negative serum pregnancy test (for
    β-hCG) within 14 days prior to randomization.
    Women of CBP must be willing to use highly effective
    methods of contraception.
    E.4Principal exclusion criteria
    -Patient with symptomatic visceral disease or any
    disease burden that makes the patient ineligible for
    endocrine therapy per the investigator’s judgment.
    -Patient who received any prior systemic anti-cancer
    therapy (including endocrine therapy, chemotherapy,
    prior CDK4/6 inhibitors) for aBC.
    i)Patients who received neo-/adjuvant therapy for
    breast cancer are eligible.
    -Patient is concurrently using other anti-cancer therapy.
    -Patient has had major surgery within 14 days prior to
    starting study drug or has not recovered from major
    toxicities.
    -Patient has received extended-field radiotherapy ≤ 4
    weeks or limited field radiotherapy ≤ 2 weeks prior to
    randomization, and has not recovered to grade 1 or
    better from related side effects of such therapy (with
    the exception of alopecia or other toxicities not
    considered a safety risk for the patient at
    investigator’s discretion).
    -Patient has a concurrent malignancy or malignancy
    within 3 years of the randomization date, with the
    exception of adequately treated basal or squamous
    cell skin carcinoma, or curatively resected cervical
    carcinoma in situ.
    -Patients with central nervous system (CNS)
    involvement unless they meet specific stability criteria.
    -Patient has clinically significant, uncontrolled heart
    disease and/or cardiac repolarization abnormality.
    -Patient is currently receiving or has received systemic
    corticosteroids ≤ 2 weeks prior to starting study drug,
    and has not fully recovered from side effects of such
    treatment
    -Other protocol-defined inclusion/exclusion may apply.
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR). ORR is based on local tumor assessments (RECIST version 1.1) for all patients that have been treated for at least 6 months or have discontinued the study treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all patients have been treated for 6 months or have discontinued study treatment.
    E.5.2Secondary end point(s)
    -Δ QTcF at Cycle 1 Day 15 (at 2h post-dose) (Key Secondary Endpoint)
    -Progression-free survival (PFS)
    -Clinical benefit rate (CBR)
    -Time to response (TTR)
    -Duration of response (DOR)
    -Pharmacokinetics (PK) of ribociclib: Cmax
    -Pharmacokinetics (PK) of ribociclib: Tmax
    -Pharmacokinetics (PK) of ribociclib: AUC0 - 24h
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all patients have been treated for 6 months or have discontinued study treatment.
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA49
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Colombia
    Costa Rica
    Czech Republic
    Finland
    France
    Germany
    Hungary
    India
    Jordan
    Lithuania
    Peru
    Portugal
    Russian Federation
    Saudi Arabia
    South Africa
    Sweden
    Thailand
    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
    End of study will be declared as the earliest occurrence of one of the following:
    -All patients have died or discontinued from the study or have been followed up for approximately 3 years from randomization.
    -Patients who in the opinion of the investigator are still deriving clinical benefit in this study can continue provision of study treatment through an alternative setting.
    -Another clinical study becomes available that can continue to provide ribociclib in this patient population
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    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: 263
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 87
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 350
    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)
    Post-study antineoplastic treatment will be at the investigator’s discretion.
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusOngoing
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