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    Summary
    EudraCT Number:2007-004574-11
    Sponsor's Protocol Code Number:CS1008-A-E202
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-12-07
    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 - PEI
    A.2EudraCT number2007-004574-11
    A.3Full title of the trial
    RANDOMISED, DOUBLE-BLINDED, PLACEBO- CONTROLLED PHASE 2 STUDY OF CS-1008 IN COMBINATION WITH CARBOPLATIN/PACLITAXEL IN CHEMOTHERAPY NAÏVE SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised study comparing placebo and a not yet approved drug CS1008, in combination with drugs Carboplatin and Paclitaxel in patients with non small cell lung cancer which has spread or can not be removed by surgery, who have not had chemotherapy treatment before. The study is double-blind (that is when neither the patient nor the investigator know which treatment the patient is receiving).
    A.4.1Sponsor's protocol code numberCS1008-A-E202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00991796
    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 Limited
    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 Pharma Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Development Limited
    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 1753 482800
    B.5.5Fax number+44 1753 899107
    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-1008
    D.3.2Product code CS-1008
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    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 INNtigatuzumab
    D.3.9.1CAS number 918127-53-4
    D.3.9.2Current sponsor codeCS-1008
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman Monoclonal Antibody
    D.IMP: 2
    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 Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderAny EU Licence Holder
    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 namePaclitaxel
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNPaclitaxel
    D.3.9.1CAS number 33069-62-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 3
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderAny EU Licence Holder
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameCarboplatin
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of metastatic or unresectable non small cell lung cancer (NSCLC) with CS 1008 or placebo first in combination with carboplatin/paclitaxel then as monotherapy in the first line setting
    E.1.1.1Medical condition in easily understood language
    Non-small cell lung cancer (NSCLC) is a general term for the most
    common form of solid cancer which affects the lungs.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 determine the difference in progression free survival (PFS) in previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC treated with CS 1008 plus carboplatin/paclitaxel versus subjects treated with placebo plus carboplatin/paclitaxel.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of CS 1008 plus carboplatin/paclitaxel;

    To evaluate the difference between the two treatment regimens CS-1008 plus carboplatin/paclitaxel and placebo (sodium Chloride) plus carboplatin/paclitaxel with respect to:
    - Overall survival (OS);
    - Objective response rate (ORR);
    - Duration of response;


    To determine the safety and tolerability of CS-1008 administered in combination with carboplatin/paclitaxel to previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed, stage IIIB wet or stage IV NSCLC.
    2. At least 18 years of age.
    3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
    4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
    5. Adequate organ and bone marrow function as evidenced by:
    - Hemoglobin >/= 9 g/dL;
    - Absolute neutrophil count >/= 1.5 x 10(e +9)/L;
    - Platelet count >/= 100 x 10(e +9)/L;
    - Serum creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min;
    - AST, ALT, and alkaline phosphatase </= 2.5 x upper limit of normal (ULN) if without liver metastasis and </
    = 5.0 x ULN if liver or bone metastasis;
    - Total bilirubin </= 1.5 x ULN.
    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 (eg, 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 ≤ 72
    hours before initiating study treatment.
    9. 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 independent ethics committee
    (IEC)-approved informed consent
    form (ICF) before performance of any study-specific procedures or tests.
    10. Life expectancy of at least 12 weeks.
    Note: symbol >/= is for greater or equal to.
    E.4Principal exclusion criteria
    1. Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study for NSCLC.
    2. No recurrent NSCLC or presence of clinically significant ascites.
    3. Prior treatment with chemotherapy investigational medicinal products, or biological treatment for NSCLC.
    4. Prior radiotherapy with curative intent for NSCLC.
    5. Palliative radiotherapy for NSCLC within 4 weeks prior to first dose.
    6. Major surgery within 4 weeks prior to first dose.
    7. History of any of the following conditions within 6 months before study enrolment: myocardial infarction;
    New York Heart Association (NYHA) class II or higher severe/unstable angina pectoris; coronary/peripheral
    artery bypass graft; NYHA class III or IV congestive heart failure; cerebrovascular accident or transient
    ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant
    pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma); clinically significant
    pulmonary edema or anasarca.
    8. Clinically significant pleural or pericardial effusions.
    9. Grade 2 or higher current peripheral neuropathy
    10. Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression
    within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or
    carcinomatous meningitis.
    11. History of malignancy other than NSCLC, unless there is the expectation that the malignancy has been cured,
    and tumor-specific treatment for the malignancy has not been administered within the previous 5 years.
    12. Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus
    (HIV)-positive subjects receiving antiretroviral therapy.
    13. Previous treatment with CS-1008, other agonistic DR 5 or DR 4 antibodies, or with TRAIL.
    14. Pregnant or breast feeding.
    15. Known history of hypersensitivity reactions to any of the components of CS-1008, carboplatin, or paclitaxel
    formulations.
    16. 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 efficacy endpoint is the difference in PFS in previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC treated with CS-1008 plus carboplatin/paclitaxel versus subjects treated with placebo plus carboplatin/paclitaxel.


    Additional exploratory assessments may include protein expression and genotype/gene expression of critical genes related to NSCLC or its treatment, possibly including but not limited to DR5, Bax, Bcl-x, cIAP, GALNT-14, and Mcl-1, in available archived tumour samples.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS data would be considered mature at 10 months after the last subject is randomised, or when 85 PFS events will have occurred, whichever is earlier.
    E.5.2Secondary end point(s)
    As per the protocol:
    • To evaluate the difference between the two treatment regimens CS-1008 plus carboplatin/paclitaxel and placebo plus carboplatin/paclitaxel with respect to:
    • Overall survival (OS);
    • Objective response rate (ORR);
    • Duration of response;
    • To determine the safety and tolerability of CS-1008 administered in combination with carboplatin/paclitaxel to previously chemotherapy naïve subjects with stage IIIB wet or stage IV NSCLC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It is projected that OS data will become mature when all subjects will have either died or been lost to follow-up, or at 24 months after the last subject is randomised, whichever is earlier. The actual final analysis date will depend on the study information.
    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 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
    Biomarker, protein and gene expression analysis
    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 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 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    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 months10
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    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)
    After the blind has been broken, subjects in the treatment arm who have tolerated the drug, and have completed 6 cycles of carboplatin/paclitaxel, and whose disease has not progressed may continue monotherapy with CS1008 at the same dose.
    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 Decision2009-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-04
    P. End of Trial
    P.End of Trial StatusCompleted
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