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    Summary
    EudraCT Number:2007-007520-17
    Sponsor's Protocol Code Number:800088NAP2001
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-06-30
    Trial 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 number2007-007520-17
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Effect of RWJ-800088 on The Prevention of Chemotherapy-Induced Anemia and The Prevention of Chemotherapy-Induced Thrombocytopenia in Subjects with Non-Small Cell Lung Cancer Receiving Gemcitabine and Either Carboplatin or Cisplatin
    A.3.2Name or abbreviated title of the trial where available
    n/a
    A.4.1Sponsor's protocol code number800088NAP2001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameRWJ-800088
    D.3.2Product code RWJ-800088
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot assigned
    D.3.9.1CAS number Notavailable
    D.3.9.2Current sponsor codeRWJ-800088
    D.3.9.3Other descriptive nameJNJ-26366821 (j&j code), SF303(UCB Bioproducts code)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 3.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 injection
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chemotherapy induced anaemia and chemotherapy induced thrombocytopenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039884
    E.1.2Term Secondary thrombocytopenia
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054606
    E.1.2Term Secondary anemia
    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 the efficacy of RWJ-800088 on the prevention of CIA in subjects with non-small cell lung cancer (NSCLC) receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of RWJ-800088 on the prevention of CIT in subjects with NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.

    To evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD)
    of RWJ-800088 in subjects with NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin.

    To evaluate the effect of RWJ-800088 on patient-reported outcome (PRO)
    assessments, and to further validate these assessments, in subjects with
    NSCLC receiving a 21-day chemotherapy regimen of gemcitabine and either
    carboplatin or cisplatin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men or women, at least 18 years of age
    2. Histologically confirmed diagnosis of stage IIIB or IV NSCLC
    3. Presence of measurable disease per RECIST criteria
    4. Candidate for up to 6 cycles of a 21-day chemotherapy regimen of gemcitabine and either carboplatin or cisplatin
    5. Body weight > 40 kg
    6. Hemoglobin ≥12.0 g/dL, but not exceeding the upper limit of the normal range, with:
    a. No need for ESAs at randomization
    b. No history of anemia due to factors other than cancer/chemotherapy (e.g., iron, B12 or folate deficiencies, hemolysis, or bleeding)
    7. Neutrophil count within normal range
    8. Platelet count within 100,000 to 450,000/µL
    9. ECOG Performance Status of 0 or 1 (Attachment 7)
    10. Creatinine clearance ≥ 40 ml/min, per Cockroft-Gault formula Estimated creatinine clearance (ml/min) = [[140 - age(yr)]*weight(kg)]/[72*serum Cr(mg/dL)]
    (multiply by 0.85 for women)
    11. Negative serum β human chorionic gonadotropin (βhCG) in women of childbearing potential
    12. Women must agree to not get pregnant during the study.
    13. Men must agree to use a double barrier method of birth control and not donate sperm from the first dose of study drug through 30 days after receiving the last dose of study drug.
    14. Willing to adhere to the prohibitions and restrictions specified in this protocol.
    15. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    16. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to consent for this component does not exclude a subject from participation in the clinical study.
    E.4Principal exclusion criteria
    1. Central nervous system metastases; with the exception of a subject with stable brain metastases following stereotactic radiosurgery (gamma knife).
    2. Prior treatment by systemic therapy or radiation for Stage IIIB or IV NSCLC
    3. Prior (within 1 year) adjuvant or neoadjuvant therapy for NSCLC
    4. Diagnosis of a myeloid malignancy or known history of myelodysplasia
    5. Hemoptysis, or active bleeding
    6. Planned nonpalliative radiation during the study. Palliative radiation is permitted, at the discretion of the investigator, if the area being treated is small (<15% of body surface area but no pelvic radiation is permitted or no more than 10% of the bone marrow reserve is irradiated).
    7. Other malignancies within 5 years prior, except carcinoma in situ of the cervix, or non-melanoma skin cancer.
    8. Systemic infection within the last 30 days or major infection requiring hospitalization and antibiotics within the last 14 days
    9. History of thrombovascular event (TVE) within the past 2 years; evidence of acute thromboembolic event in the last 45 days
    10. Transfusion of platelets or RBCs within 28 days before the planned first dose administration of study medication
    11. Neuropathy > Grade 1
    12. Currently receiving therapeutic or prophylactic heparin or low molecular weight heparin anticoagulants (warfarin is permitted) or anti-platelet therapy (aspirin and NSAIDS are permitted).
    13. Use of growth factors (e.g. G-CSF, GM-CSF, erythropoietins) or IL-11 within 28 days prior to planned first dose of study drug.
    14. Prior use of Avastin or Erbitux
    15. Received an experimental drug or used an experimental medical device within 30 days prior to planned first dose of study drug administration.
    16. Serology positive for hepatitis B surface antigen (HbsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies.
    17. History of life threatening allergic reactions to food or drugs,including those related to RWJ-800088 (e.g., AMG531, rh-TPO or PEG-MDGF).
    18. Major surgery within 30 days prior to Screening visit and/or planned surgery
    with a risk of blood loss.
    19. Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence rate of the composite endpoint of Grade 2 or higher anemia, or a ≥ 2 g/dL drop in hemoglobin on the first day of any chemotherapy cycle (Cycle 2 to 6) relative to baseline (Cycle 1, Day 1), or the use of rescue intervention for anemia (e.g., erythropoiesis stimulating agents [ESAs], red blood cell [RBC] transfusion).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    proteomics
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 No
    E.8.5.1Number of sites anticipated in the EEA4
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last subject last visit (see section 16.9.1)
    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 months8
    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 months11
    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.1.3Elderly (>=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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 148
    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)
    see protocol (section 9.1.4: posttreatment phase)
    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 Decision2008-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-25
    P. End of Trial
    P.End of Trial StatusOngoing
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