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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-004010-28
    Sponsor's Protocol Code Number:I3Y-MC-JPBO
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-08-19
    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 number2014-004010-28
    A.3Full title of the trial
    A Phase 2 Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer That Has Spread to the Brain
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02308020
    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 SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 nameAbemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Capsule
    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 INNNot available
    D.3.9.1CAS number 1231929-97-7
    D.3.9.3Other descriptive nameLY2835219
    D.3.9.4EV Substance CodeSUB88440
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Brain tumours, Breast Cancer
    E.1.1.1Medical condition in easily understood language
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic 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
    To evaluate abemaciclib with respect to objective intracranial response rate (OIRR; complete response [CR] + partial response [PR]) based on tumor assessments and brain metastases response criteria in women with brain metastases secondary to HR+, HER2+ and HR+, HER2- breast cancer.
    E.2.2Secondary objectives of the trial
    To evaluate abemaciclib with respect to:
    • Intracranial disease per brain metastases response criteria
    - Best overall intracranial response (BOIR)
    - Duration of intracranial response (DOIR) (CR + PR)
    - Intracranial disease control rate (IDCR) (CR + PR + stable disease [SD])
    - Intracranial clinical benefit rate (ICBR) (CR + PR + SD ≥6 months)
    • Overall
    - OS
    - Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and brain metastases response criteria
    - Disease control rate (DCR) (CR+ PR+ SD) per RECIST v1.1 and brain metastases response criteria
    - Progression free survival (PFS) per RECIST v1.1 and brain metastases response criteria

    Change in symptoms as assessed by MD Anderson Symptom Inventory – Brain Tumor (MDASI-BT)
    To evaluate the safety and tolerability
    To determine the pharmacokinetics (PK) and its metabolites
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] have histologically confirmed HR+ metastatic breast cancer. To fulfill the requirement for HR+ disease, a breast cancer must express, at least 1 of the hormone receptors (ER or progesterone receptor [PgR]). For ER and PgR assays to be considered positive, ≥1% of tumor cell nuclei must be immunoreactive by immunohistochemistry (IHC)
    [2] For Part A: have confirmed HER2 overexpression (HER2+) status. To fulfill the requirement for HER2+ disease, tumor tissue must demonstrate 3+ by IHC or gene amplification by in-situ hybridization (ISH). For Part B: have disease which does not demonstrate HER2 overexpression (HER2-) by either IHC or ISH. For Part C (surgical): have either HER2+ or HER2- status with brain lesion(s) for which surgical resection is clinically indicated and agree to provide posttreatment (5 to 14 days after initiating abemaciclib) brain tumor tissue.
    [3] For Parts A and B: have ≥1 new or not previously irradiated measurable metastatic brain lesion ≥10 mm in the longest diameter (LD) or a progressive previously irradiated metastatic brain lesion on radiographic imaging by gadolinium-enhanced magnetic resonance imaging (Gd MRI). Note: for patients with prior WBRT or SRS, previously irradiated lesion(s) must demonstrate unequivocal progression on baseline Gd MRI in the opinion of the investigator. Otherwise new or not previously irradiated lesions must be present. For Part C (surgical): have 1 to 3 metastatic brain lesion(s) for which surgical resection is clinically indicated.
    [4] have completed local therapy (surgical resection, WBRT, or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects. Patients are not required to have received prior local therapy for study participation.
    [5] if receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
    [6] have a Karnofsky performance status of ≥70
    [7] have a life expectancy ≥12 weeks.
    [8] if currently receiving endocrine therapy, a patient may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and intracranial disease progression has occurred while on this endocrine therapy. If these conditions are not met, patients must discontinue endocrine therapy prior to initiation of abemaciclib.
    [9] have discontinued all previous therapies for cancer (including cytotoxic chemotherapy, targeted therapy [including, but not limited to, everolimus], radiotherapy, immunotherapy, and investigational therapy) for at least 14 days prior to receiving abemaciclib and recovered from the acute effects of therapy (treatment related toxicity resolved to baseline) except for residual alopecia or peripheral neuropathy. Note: patients currently receiving trastuzumab and receiving clinical benefit may continue to receive trastuzumab throughout the study. Concurrent treatment with trastuzumab emtansine (T-DM1) is not allowed.

    [10] for patients receiving concurrent trastuzumab, must have left ventricular ejection fraction within investigative site’s normal range.
    [11] have adequate organ function including:
    • Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 8 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator.
    • Hepatic: Bilirubin ≤ 1.5 times upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 times ULN (or ALT and AST ≤5 times ULN if liver metastases are present).
    • Renal: Serum creatinine ≤ 1.5 times ULN.
    [12] are female and ≥ 18 years of age.
    [13] if a female of childbearing potential, must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a medically approved nonhormonal contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
    [14] are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
    [15] are able to swallow capsules.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [16] require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
    [17] require concurrent anticancer treatment at any time during the study treatment period. Note: exceptions are endocrine therapy, trastuzumab (HER2+ patients), or surgical resection (Part C patients only).
    [18] are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
    [19] have evidence of significant (ie, symptomatic) intracranial hemorrhage.
    [20] have evidence of leptomeningeal metastases on brain Gd-MRI or by previously documented CSF cytology. Note: discrete dural metastases are permitted.
    [21] have experienced >2 seizures within 4 weeks prior to study entry.
    [22] have visceral crisis. Visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease.
    [23] have previously received treatment with any CDK4/6 inhibitor.
    [24] have known contraindication to Gd-MRI.
    [25] are currently receiving lapatinib.
    [26] are currently enrolled in a clinical trial involving an investigational product or nonapproved use of a drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    [27] have received treatment with a drug that has not received regulatory approval for any indication within 14 days of the initial dose of abemaciclib.
    [28] have a personal history within the last 12 months of any ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest.
    [29] have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel).
    [30] have a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea.
    [31] have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
    [32] are lactating.
    [33] have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrollment.
    [34] have an acute bacterial infection requiring intravenous antibiotics.
    [35] have received recent (within 28 days of initial dose of abemaciclib) or concurrent yellow fever vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Intracranial Response Rate (OIRR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to Objective Disease Progression (Approximately 6 Months)
    E.5.2Secondary end point(s)
    Best Overall Intracranial Response (BOIR)
    Duration of Intracranial Response (DOIR)
    Intracranial Clinical Benefit Rate (ICBR)
    Overall Survival
    Objective Response Rate (ORR)
    Disease Control Rate (DCR)
    Progression Free Survival
    Change from Baseline to End of Study in Neurologic Symptoms on the MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) Scale
    Pharmacokinetics (PK): Minimum Concentration (Cmin) of Abemaciclib and its Metabolites
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to Earliest Objective Progression or Start of New Anticancer Therapy (Approximately 6 Months)
    Date of Complete Response or Partial Response to Date of Objective Disease Progression or Death from Any Cause (Approximately 6 Months)
    Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months)
    Baseline to Death from Any Cause (Approximately 18 Months)
    Baseline to Disease Progression (Approximately 6 Months)
    Baseline to Disease Progression or Start of New Anticancer Therapy (Approximately 6 Months)
    Baseline to Objective Disease Progression or Death from Any Cause (Approximately 6 Months)
    Baseline, End of Study (Approximately 6 Months)
    Cycle 1 through Cycle 4 (Approximately 3 Months)
    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 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 trial3
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Austria
    Belgium
    Canada
    France
    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 trial refers to the date of the last visit or last scheduled procedure for the last patient. The end of trial occurs after study completion and after the last patient has discontinued study treatment and completed any applicable continued access follow-up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years2
    E.8.9.2In all countries concerned by the trial months3
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 120
    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-treatment discontinuation follow up starts just after the last dose of study drug and ends when final safety assessments are completed 30 days (±7) after last dose of study drug. Long term follow up begins after the day short term post discontinuation follow up visits is completed and continues until the patient’s death, lost to follow-up, or overall study completion.
    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 Decision2015-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-27
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