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    Summary
    EudraCT Number:2015-005069-21
    Sponsor's Protocol Code Number:I4D-MC-JTJH
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-005069-21
    A.3Full title of the trial
    A Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial in Patients with Extensive Small Cell Lung Cancer
    A.4.1Sponsor's protocol code numberI4D-MC-JTJH
    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 and Company
    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 nameLY2606368
    D.3.2Product code LY2606368
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1234015-57-6
    D.3.9.2Current sponsor codeLY2606368
    D.3.9.3Other descriptive nameLY2606368
    D.3.9.4EV Substance CodeSUB176839
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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
    Extensive Disease Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Extensive Disease Small Cell Lung 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 PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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
    Cohort 1: To estimate the Overall Response Rate (ORR) when a dose of 105 mg/m2 LY2606368 every 14 days is administered to patients with ED-SCLC that have platinum-sensitive disease.

    Cohort 2: To estimate the ORR when a dose of 105 mg/m2 LY2606368 every 14 days is administered in patients with Extensive-stage Disease Small Cell Lung Cancer (ED-SCLC) that have platinum resistant/refractory disease.
    E.2.2Secondary objectives of the trial
    -To characterize the safety and toxicity profile of LY2606368
    -To characterize the pharmacokinetics (PK) of LY2606368
    -To estimate secondary efficacy measures including disease control rate (DCR), duration of response (DoR), progression free survival (PFS), and overall survival (OS)
    - To evaluate the association between best tumor response and change from baseline in lung cancer-specific symptoms, symptomatic distress, activity status, overall quality of life, total Lung Cancer Symptom Scale (LCSS) score and Average Symptom Burden Index (ABSI) for patients who have platinum-sensitive or platinum-resistant/refractory SCLC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol Addendum I4D-MC-JTJH(2) - Approval Date: 10-Jul-2017 - A
    Phase 2 Study of LY2606368 in Patients with Extensive Stage Disease
    Small Cell Lung Cancer
    Objectives:
    - To document any antitumor activity when LY2606368 is administered
    on Days 1, 2, and 3 of a 14-day cycle in patients with ED-SCLC that have
    platinum-sensitive disease
    - To characterize the safety and toxicity profile of LY2606368 when
    administered on Days 1, 2, and 3 of a 14-day cycle
    - To characterize the PK of LY2606368 when administered on Days 1, 2,
    and 3 of a 14-day cycle
    - To explore the biomarkers associated with the efficacy and safety of
    LY2606368, the exposure (PK) of LY2606368, the mechanism of action
    of CHK1, DNA damage response pathways or downstream effects, cell
    cycle markers, immune
    function, or cancer pathobiology
    15 patients in total will be enrolled in the addendum. 10 patients
    planned in Spain. The other 5 patients will be in the US.
    Participating sites in Spain will be site 603- Dr Olmedo and site 604- Dr
    Navarro
    E.3Principal inclusion criteria
    -Have histological or cytological diagnosis of ED-SCLC and received a prior platinum-based regimen. Cohort 1 must have had an objective response to prior platinum-based therapy with subsequent progression >= 90 days after the last dose of platinum. Cohort 2 must either have had an objective response to prior platinum based therapy or had progression < 90 days after the last dose of platinum
    -Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale
    -Have at least 1 measurable lesion using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
    -Have adequate organ function, including:
    Hematologic: Absolute Neutrophil Count (ANC) >= 1.5x 10^9/L, platelets >= 100 x 10^9/L, Hemoglobin >= 8 g/dL or >=5 mmol
    Hepatic: direct bilirubin <= 1.5 x ULN, ALT and AST <= 2.5 x ULN or <= 5 x ULN (if the liver has involvement)
    Renal: Serum creatinine, or measured creatinine clearance, or calculated creatine clearance (using the Chronic Kidney Disease Epidemiology Collaboration (CKP-EPI) equation) < 1.5 x ULN or >= 50 mL/min/1.73 m^2
    -Men must be sterile or agree to use an effective method of birth control during the study and for at least 12 weeks following the last dose of LY2606368
    -Women must have a negative serum pregnancy test at screening, have another negative urine pregnancy test within 7 days prior to the first dose of LY2606368, and agree to use a highly effective method of birth control during the study and for 12 weeks following the last dose of LY2606368. Women on study must also not breastfeed.
    E.4Principal exclusion criteria
    -Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
    -Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic patients with treated CNS metastases should be stable for at least 14 days by clinical assessment, and patients should not have received corticosteroids to treat CNS metastases within 14 days of the first dose of study drug.
    -Have a second primary malignancy that may affect the results of the study (investigator and study sponsor discretion)
    -Have previously completed or withdrawn from this study or any other study investigating LY2606368 or a CHK 1 Inhibitor
    -Have serious pre-existing medical conditions (left to the discretion of the investigator)
    -Have a serious cardiac condition
    - Have QTc interval of > 470 msec on more than one screening ECG
    -Have a family history of long QT-syndrome
    -Have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C (screening is not required). If the medical history, symptoms, and/or laboratory values suggest the patient may have HIV or hepatitis A, B, or C, appropriate assessment should be conducted to determine whether the patient should be excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response as determined by RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessment starting at 6 weeks and continuing every 6 weeks until disease progression or participant discontinuation (estimated 14 weeks)
    E.5.2Secondary end point(s)
    -AEs and laboratory measurements
    -PK profile of LY2606368: maximum concentration (Cmax) and time of maximal concentration (tmax)
    -Disease control rate
    -Duration or response
    -Progression free survival
    -Overall survival
    -Lung cancer symptoms and global quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Weekly during treatment and 30 days after treatment (estimated 18 weeks)
    -Cmax and tmax: either post dose and/or predose LY2606368 (estimated 14 weeks)
    -Best overall response: radiologic assessment starting at 6 weeks and continuing every 6 weeks until disease progression (estimated at 14 weeks)
    -Time from an objective response assessment until disease progression or death from any cause in absence of progressive disease (estimated at 14 weeks)
    -Time from enrollment until the first radiographic documentation of progressive disease or death from any cause in absence on progressive disease (estimated at 18 weeks)
    -Time from enrollment until death from any cause (estimated at 15 months)
    -Lung cancer symptoms, total LCSS and ASBI (estimated at 42 weeks)
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Health outcomes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    France
    Germany
    Greece
    Korea, Republic of
    Netherlands
    Spain
    Turkey
    Ukraine
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 92
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 39
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 131
    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)
    Patient will be monitored for safety 30 days after the last day of treatment. Patient will be followed for survival approximately every 60 days following their initial 30 day discontinuation follow-up visit until the patient dies or is lost to follow-up.
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-20
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