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    Summary
    EudraCT Number:2008-005848-16
    Sponsor's Protocol Code Number:CS7017-A-E201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-04-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-005848-16
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE 2 STUDY OF CS-7017 IN COLORECTAL CANCER PATIENTS WHO HAVE ACHIEVED DISEASE CONTROL FOLLOWING FIRST-LINE CHEMOTHERAPY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CS7017 in CR cancer patients with disease control post 1st line therapy
    A.4.1Sponsor's protocol code numberCS7017-A-E201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00986440
    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 SponsorDaiichi Sankyo Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportDaiichi Sankyo Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChiltern Place, Chalfont Park
    B.5.3.2Town/ cityGerrards Cross, Buckinghamshire
    B.5.3.3Post codeSL9 0BG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 (0)1753 482 800
    B.5.5Fax number+44 (0)1753 899 107
    B.5.6E-mailinfo@dsd-eu.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 nameCS-7017
    D.3.2Product code CS-7017
    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.3.9.1CAS number 1048002-36-3
    D.3.9.2Current sponsor codeCS-7017
    D.3.9.3Other descriptive nameCS7017
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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 placeboFilm-coated tablet
    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
    Stage III and IV Colorectal Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of the colon and rectum (colorectal cancer) can invade and damage tissues and organs. Tumors of the colon/ rectum are growths of the inner wall of the large intestine.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10010035
    E.1.2Term Colorectal cancer stage IV
    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
    The primary objective is to compare the progression free survival (PFS) rate of colorectal cancer patients treated with CS-7017 or placebo at 18 weeks in patients who have achieved a response of disease control (complete response [CR],partial response [PR] or stable disease [SD]) to standard first line therapy.
    E.2.2Secondary objectives of the trial
    1/ Compare the overall PFS and overall survival (OS) of patients treated with CS-7017 or placebo and

    2/ Compare the safety parameters of patients treated with CS-7017 or placebo

    3/ Pharmacokinetic Objectives:
    The pharmacokinetic objective is to analyse the population PK of CS-7017.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histologically-confirmed, metastatic or locally advanced CRC
    (stages III or IV) and must have received standard first line combination
    chemotherapy:
    a) Patients must receive their primary treatment until 1 cycle beyond their best
    response (disease control) has been reached, i.e., CR, PR or SD as
    determined by the Investigator;
    b) Patients must enter the trial within 8 weeks after completing first line therapy;
    c) Standard first line combination chemotherapy can consist of a fluoropyrimidine
    based regimen:
    i) FOLFOX (folinic acid + fluoropyrimidine + oxaliplatin); or
    ii) FOLFIRI (folinic acid + fluoropyrimidine + Irinotecan); or
    iii) Other fluoropyrimidine based regimens, e.g., XELOX (capecitabine +
    oxaliplatin) and the use of a fluoropyrimidine based regimen;
    iv) Also, a biological adjunct such as bevacizumab is allowed in combination
    with such fluoropyrimidine based regimens;

    2. A minimum of one unidimensionally-measurable target lesion according to
    RECIST (Response Evaluation Criteria in Solid Tumors, Version 1.0);20, unless
    CR was achieved;

    3. Age ≥ 18 years and Eastern Cooperative Oncology Group (ECOG) performance
    status ≤ 2 at study entry;

    4. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE,
    Version 3.0, grade ≤ 1;

    5. Adequate organ and bone marrow function as evidenced by:
    · Haemoglobin ≥ 10 g/dL (transfusion and/or growth factor support allowed);
    · Absolute neutrophil count (ANC) ≥ 1.5 x 109/L;
    · Platelet count ≥ 100 x 109/L;
    · Serum creatinine ≤ 1.5 x ULN or creatinine clearance >60 mL/min;
    · AST and alkaline phosphatase <2.5 x ULN if without liver metastasis and ≤
    5.0 x ULN if liver metastasis;
    · Total bilirubin ≤ 2.0 x ULN;
    · Prothrombin time (PT)/International Normalised Ratio (INR) within normal
    limits (WNL) unless therapeutically anticoagulated;

    6. Women of childbearing potential and men must be willing to consent to using
    highly effective methods of contraception (eg, hormonal contraceptives, bilateral
    tubal ligation, barrier with spermicide, intrauterine device) while on treatment and
    for at least 3 months thereafter;

    7. Males with the potential to father children and women of childbearing
    potential must use two of the following methods of contraception acceptable for
    the study (e.g. hormonal contraceptives, bilateral tubal ligation, barrier with
    spermicide, intrauterine device) while on trial treatment and for at least 3 months
    thereafter;

    8. All female subjects of childbearing potential must have a negative pregnancy test
    (serum or urine) result within 7 days before initiating study treatment;

    9. Baseline laboratory tests must have been performed within 2 weeks before
    initiating study treatment and baseline tumour assessment must have been
    performed within 28 days before initiating study treatment;


    10. Subjects must be fully informed about their illness and the investigational nature
    of the study protocol (including foreseeable risks and possible side effects) and
    must sign and date an IEC-approved ICF before performance of any
    study-specific procedures or tests.

    E.4Principal exclusion criteria
    1. Anticipation of need for a major surgical procedure or radio therapy during the study;

    2. Treatment for cancer with chemotherapy, hormonal therapy, minor surgery, or any investigational agent within 4 weeks before study enrolment. Treatment with immunotherapy, biological therapy, or major surgery within 6 weeks before study enrolment. Treatment with RT within 1 week before study enrolment.

    3. History of any of the following conditions: diabetes mellitus requiring treatment with insulin or oral agents, malabsorption syndrome, chronic diarrhoea (lasting ≥4 weeks duration), inflammatory bowel disease, or partial bowel obstruction;

    4. Concomitant use of other TZDs;

    5. Any of the following clinically significant conditions within 6 months before enrolment: myocardial infarction, NYHA Class II or higher severe/unstable angina pectoris (See Section 17.2), coronary/peripheral artery bypass graft; congestive heart failure; cerebrovascular accident or transient ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant pulmonary disease (e.g., severe COPD or severe asthma); clinically significant pulmonary oedema;

    6. Brain metastasis; an uncontrolled seizure disorder; spinal cord compression; or carcinomatous meningitis;

    7. Clinically significant pleural or pericardial effusion. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor;

    8. Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus (HIV) positive subjects receiving antiretroviral therapy;

    9. Pregnant or breast feeding;

    10. Known history of severe hypersensitivity reactions to any of the components of CS 7017 formulations;

    11. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or safety of the study treatment;
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the rate of progression free survival (PFS) at 18 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 weeks.
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are PFS and overall survival and safety endpoints (ie, AEs and clinical laboratory evaluations).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival.
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    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 No
    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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Czech Republic
    France
    Germany
    Italy
    Poland
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    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
    The clinical end of trial will be defined as the date of the last subject's follow up visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 170
    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)
    After the blind has been broken, subjects in the treatment arm who tolerate the drug and whose disease has not progresses may have the opportunity to continue therapy on a separate open-label protocol.
    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 Decision2009-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2012-05-31
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