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    Summary
    EudraCT Number:2013-005548-27
    Sponsor's Protocol Code Number:I3Y-MC-JPBN
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-04-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-005548-27
    A.3Full title of the trial
    A Phase 2 Study of LY2835219 for Patients with Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in patients with metastatic breast cancer who have not responded to previous treatment.
    A.3.2Name or abbreviated title of the trial where available
    JPBN
    A.4.1Sponsor's protocol code numberI3Y-MC-JPBN
    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 States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly Benelux
    B.5.2Functional name of contact pointSite Activation Team
    B.5.3 Address:
    B.5.3.1Street AddressRue du marquis 1/4B Markiestraat
    B.5.3.2Town/ cityBruxelles/Brussel
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number00322548 8627
    B.5.5Fax number00322548 8474
    B.5.6E-mailtassin_virginie@network.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.3.2Product code LY2835219
    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.3.9.1CAS 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
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10055113
    E.1.2Term Breast cancer metastatic
    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 LY2835219 with respect to objective response rate (ORR) (complete response [CR] + partial response [PR]).
    E.2.2Secondary objectives of the trial
    •Safety and tolerability of LY2835219 using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03)
    • Overall survival (OS)
    • Duration of response (DoR) (CR + PR)
    • Progression-free survival (PFS)
    • Disease control rate (DCR) (CR + PR + stable disease [SD])
    • Clinical benefit rate (CBR) (CR + PR + SD ≥ 6 months)
    • Impact on pain, disease symptoms, and overall quality of life using the modified
    Brief Pain Inventory-Short Form (mBPI-sf) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core
    • Pharmacokinetics (PK) of LY2835219 and its metabolites
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Have a diagnosis of HR+, HER2- breast cancer:
    - To fulfill the requirement of HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the hormone receptors (estrogen receptor [ER] or progesterone receptor).
    - To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization
    •Have the following:
    - Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
    - Prior treatment with at least 2 chemotherapy regimens, with at least one administered in the metastatic setting and at least one must have contained a taxane. The additional chemotherapy regimens could have included any of the following: capecitabine, eribulin, gemcitabine, an anthracycline, or vinorelbine.
    - No more than 2 prior chemotherapy regimens in the metastatic setting.
    • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
    • Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and endocrine therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at lease Grade 1) except for residual alopecia and peripheral neuropathy.
    • Have adequate organ function, including:
    - Hematologic: absolute neutrophil count (ANC) ≥1.5 × 109/L, platelets ≥100 × 109/L, hemoglobin ≥8 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
    - Hepatic: bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) ≤3 × ULN.
    - Renal: serum creatinine ≤ULN.
    • Are female and ≥18 years of age.
    • If a woman of child-bearing potential, must test negative for pregnancy at the time of enrollment based on serum pregnancy test, and agree to use a reliable method of birth control during the study and for 3 months following the last dose of the study drug.
    • Have the presence of measureable disease as defined by RECIST Version 1.1 (Eisenhauer et al. 2009).
    E.4Principal exclusion criteria
    • Have either a history of central nervous system metastasis (CNS) or evidence of CNS metastasis on the MRI of brain obtained at baseline.
    • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. Patients are not eligible if they have received prior therapy with another CDK4/6 inhibitor.
    • Have had major surgery within 14 days of the initial dose of study drug.
    • Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
    • 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.
    • Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
    • Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV] antibodies, hepatitis B surface antigen, or hepatitis C antibodies). Screening is not required for enrollment.
    • Are lactating women.
    • Have initiated approved bisphosphonates or approved RANK ligand targeted agents (for example, denosumab) ≤28 days prior to Day 1 of Cycle 1.
    • Have received recent (within 28 days of initial dose of study drug) or yellow fever vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Response as defined by RECIST 1.1. (Eisenhauer et al. 2009). A responder is defined as any patient who exhibits a confirmed Complete Response (CR) or Partial Response (PR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 4 weeks before the first dose, baseline tumor measurements will be performed on each patient.

    A second assessment must be performed 28 days after the first evidence of response.

    Two objective status determinations of CR before progression are required for a best response of CR.

    Two determinations of PR or better before progression, but not qualifying for a CR, are required for a best response of PR. Best response of SD is defined as disease that does not meet the criteria for CR, PR, or PD and has been evaluated at least 1 time, at least 6 weeks after the start of study treatment.

    Best response will be derived to encompass all tumor assessments from baseline until the earliest of objective progression or start of new anticancer therapy.
    E.5.2Secondary end point(s)
    • Safety and tolerability of LY2835219 using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03)
    • overall survival (OS)
    • duration of response (DoR) (CR + PR)
    • progression-free survival (PFS)
    • disease control rate (DCR) (CR + PR + stable disease [SD])
    • clinical benefit rate (CBR) (CR + PR + SD ≥ 6 months)
    • impact on pain, disease symptoms, and overall quality of life using the modified Brief Pain Inventory-Short Form (mBPI-sf) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Duration of Response-The time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier.
    • Progression-Free Survival- The time from the date of study enrollment (randomization) to the date of first observation of objective progression or death from any cause whichever is earlier
    • Overall Survival- The time from the date of study enrollment to the date of death from any cause
    • Disease Control Rate The percentage of patients with a best response of CR, PR, or SD
    • Clinical Benefit Rate The percentage of patients with a best response of CR or PR, or SD for at least 6 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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    ECG, QT Interval
    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 EEA10
    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
    Belgium
    France
    Italy
    Spain
    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
    Date of the last visit or last scheduled procedure for the last patient.
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 128
    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)
    The extension period begins after study completion and ends at the end of trial. During the extension period, patients on study therapy who continue to experience clinical benefit may continue to receive study therapy until one of the criteria for discontinuation is met. The extension period includes extension period follow-up.


    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation US Oncology
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Sarah Cannon Research Institute
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-22
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