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    Summary
    EudraCT Number:2008-007690-21
    Sponsor's Protocol Code Number:42160443PAI2001
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-17
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2008-007690-21
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Cancer-Related Pain, Followed by an Open-Label Extension Phase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the safety and effectiveness of JNJ-42160443 as add-on treatment in patients with cancer-related pain
    A.4.1Sponsor's protocol code number42160443PAI2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00929188
    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 SponsorJanssen Cilag International NV, 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 supportJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group - Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 nameJNJ-42160443-AAA - solution for injection - 10 mg/mL
    D.3.2Product code JNJ-42160443
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-42160443-AAA
    D.3.9.3Other descriptive nameJNJ-42160443
    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 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 Yes
    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 typeFully human recombinant monoclonal antibody (IgG2)
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain
    E.1.1.1Medical condition in easily understood language
    Pain, Burning
    Pain, Crushing
    Pain, Migratory
    Pain, Radiating
    Pain, Splitting
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10058019
    E.1.2Term Cancer pain
    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 of this study is to evaluate the analgesic efficacy, safety, and tolerability of a single SC dose (9 mg in 0.9 mL) of JNJ-42160443 compared with placebo as adjunctive therapy to standard pain therapy in subjects with inadequately controlled, moderate to severe, chronic, cancer-related pain.
    The primary efficacy objective of this study is to evaluate the analgesic effect of JNJ-42160443 compared with placebo, as measured by the change from baseline to the end of the double-blind treatment phase in the average cancer-related pain intensity score, using an 11-point numerical rating scale (NRS), with 0=no pain and 10=pain as bad as you can imagine.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate the efficacy of JNJ-42160443 compared with placebo, as measured by the Brief Pain Inventory (BPI) Short Form, Patient Global Impression of Change (PGIC), and baseline and breakthrough opioid use and to evaluate the immunogenicity (antibodies to JNJ-42160443) associated with JNJ-42160443 treatment, to examine the pharmacokinetics of JNJ-42160443.

    Exploratory Objectives
    The exploratory objectives of this study are to investigate the effects of improvements in pain relief with JNJ-42160443 on symptoms common in terminally ill subjects with cancer-related pain, including fatigue, sleep disturbance, emotional distress, aspects of daily activities, and anxiety/depression.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Terminally ill cancer patients as per judgment of the investigator (eg, subjects who are in or who are candidates for hospice or palliative care for end-of-life management.
    • Diagnosis of moderate to severe pain directly related to an active cancer that is not controlled by standard pain treatments
    • Receiving a stable dose of opioid pain medications for at least 1 week before screening
    • If receiving nonopioid pain medications, must be at stable dose for 1 week before screening
    • Have an average daily pain intensity score of >=4 averaged over the last 3 days before treatment assignment, >= 5 for the worst pain score during the last 3 days before randomization, and a minimum single score of average pain intensity must be >=2
    E.4Principal exclusion criteria
    • Planned major surgical procedures during the double-blind treatment phase that may affect study outcomes.
    • Prior treatment with any other investigational NGF inhibitor therapy
    • Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients, including mammalian cell-derived (ie, Chinese hamster ovary) products
    • Enrolled in any investigational study within the previous 4 weeks or 5 half-lives of the investigational drug (whichever is longer), or are currently enrolled in another investigational study at the time of screening
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy evaluation is the average cancer-related pain intensity in the last 24 hours recorded daily in the diary during the double-blind treatment phase using an 11-point NRS, with 0=no pain and 10=pain as bad as you can imagine.

    The primary efficacy endpoint is the change from baseline to the end of the double-blind treatment phase in the average cancer-related pain intensity score, averaged over the last 3 days before randomization and over the last 7 days of the double-blind treatment phase. The average cancer-related pain intensity score is based on the average pain in the last 24 hours item recorded daily in the diary.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (average cancer-related pain intensity score over the last 3 days before randomization) to the end of Week 4 (average cancer-related pain intensity score over the last 7 days of the double-blind treatment phase)
    E.5.2Secondary end point(s)
    1 - Change in pain intensity and interference item scores of the BPI Short Form
    2 - PGIC
    3 - Change in "how much pain you have right now" scores
    4 - Change in "pain at its worst in the past 24 hours"
    5 - Change in total opioid use
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - End of Week 4, Week 52, and Week 60 for pain intensity; End of Week 4 for BPI
    2 - At Visits 4, 6, 8, 10
    3 - End of Week 4, Week 52, and Week 60
    4 - End of Week 4, Week 52, and Week 60
    5 - End of Week 4
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Yes
    E.8.1.7.1Other trial design description
    Followed by an Open-Label Extension Phase
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Canada
    Portugal
    Spain
    Poland
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 90
    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 study completion, the investigator will assess the subjects’ needs for analgesics to determine appropriate options for pain care.
    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 Decision2009-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-19
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