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    Summary
    EudraCT Number:2011-001076-18
    Sponsor's Protocol Code Number:26481585LYM2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-07-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-001076-18
    A.3Full title of the trial
    A Phase 2, Single-arm, Open-label, Multicenter Study of the Histone
    Deacetylase Inhibitor (HDACi) JNJ-26481585 in Subjects With Previously
    Treated Stage Ib-IVa Cutaneous T-cell Lymphoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Histone Deacetylase Inhibitor (HDACi) JNJ-26481585 in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma (CTCL)
    A.4.1Sponsor's protocol code number26481585LYM2001
    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
    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 supportJanssen Research & Development
    B.4.2CountryBelgium
    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- Archimdesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+ 31(0)715242166
    B.5.5Fax number+ 31(0)715242110
    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.3.2Product code JNJ-26481585
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeJNJ-26481585
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 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 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.3.2Product code JNJ-26481585
    D.3.4Pharmaceutical form Capsule
    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.3.9.2Current sponsor codeJNJ-26481585
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) 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
    Stage Ib-IVa Cutaneous T-cell Lymphoma
    E.1.1.1Medical condition in easily understood language
    Cutaneous T-cell Lymphoma (CTCL)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10011677
    E.1.2Term Cutaneous T-cell lymphoma
    E.1.2System Organ Class 100000004864
    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 determine the overall cutaneous response rate (RR) based on the modified Severity Weighted Assessment Tool (mSWAT) criteria.
    E.2.2Secondary objectives of the trial
    * To determine the overall global RR based on consensus global response score for mycosis fungoides (MF) / Sézary Syndrome (SS) (mSWAT + nodes/viscera + blood)
    * To evaluate the safety profile of JNJ-26481585
    * To determine the duration of response (DOR)
    * To estimate progression free survival (PFS)
    * To estimate 1-year overall survival rate
    * To explore the effect of JNJ-26481585 on symptoms and capacity to function [patient reported outcomes (PROs)]
    * To assess pharmacodynamic markers of JNJ-26481585 activity in tumor biopsies and surrogate tissues
    * To explore biomarkers predictive of response to JNJ-26481585
    * To explore the population pharmacokinetics of JNJ-26481585
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place
    2. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2
    3. Histopathologically confirmed CTCL, either mycosis fungoides or Sézary syndrome Stage Ib-IVa
    4. Relapsed or refractory disease following at least 1 prior systemic therapy for CTCL. PUVA is considered skin-directed therapy and not systemic therapy. Subjects must have recovered from toxicity related to prior systemic therapy after at least a 2-week wash-out period.
    5. Stable anti-pruritus regimen (topical corticosteroids or antihistamine) in the preceding 28 days.
    6. Measurable disease with at least 1 skin lesion (patch, plaque, or tumor) ≥ 1 cm in the longest diameter
    7. Adequate liver function as determined by serum total bilirubin levels ≤1.5 x upper limit of normal (ULN), and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels ≤2.5 x ULN
    8. Adequate bone marrow function, as determined by an absolute neutrophil count (ANC)≥1200/mm3 (or ≥1.2x10 to the 9th/L); a platelet count ≥100,000/mm3 (or ≥100x10 to the 9th/L) and
    a hemoglobin level greater than 9 g/dL (or≥90 g/L), in the absence of transfusion requirements or cytokine support for 7 days prior to enrolling on the study
    9. Serum potassium, calcium (corrected for albumin level), magnesium must be within institutional normal limits.Electrolyte supplementation is recommended to maintain electrolyte levels toward the high end of the normal limits (see Section 8.2).
    10. LVEF within institutional normal limits, as determined by MUGA or echocardiography
    11. Adequate renal function as determined by serum creatinine levels ≤1.5xULN
    12. If a woman, before study entry she must be
    * postmenopausal (> 45 years of age with amenorrhea for at least 18 months)
    * surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy)
    * if heterosexually active, practicing an effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization) before enrollment, throughout the study, and up to 6 months after stopping study drug
    13. Negative pregnancy test (urine or serum β-hCG) at Screening (applicable to women of child bearing potential who are sexually active) at most 7 days prior to starting treatment
    14. Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug
    15. Subjects must have signed an informed consent document indicating that they understand the purpose and procedures required, 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 give consent for this component does not exclude a
    subject from participation in the clinical study
    E.4Principal exclusion criteria
    1. Prior histone-deacetylase inhibitor therapy for CTCL
    2. Concurrent systemic corticosteroid dose > 10 mg/day of prednisone or equivalent (stable use of ≤10 mg/day of prednisone for ≥1 month before study entry is allowed)
    3. Major surgery or radiotherapy within 3 weeks before study drug administration. Focal radiotherapy for local disease control is allowed. Subjects must have recovered from prior radiotherapy or surgery related toxicity
    4. Other malignancy within past 5 years. Exceptions include: basal or non-metastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Fédération Internationale de Gynécologie et d’Obstétrique Stage 1 carcinoma of the cervix, prostate intraepithelial neoplasia and biochemical relapse free ≥ 3 years
    5. Unstable angina or myocardial infarction within the preceding 12 months; congestive heart failure New York Heart Association Class II-IV; known presence of dilated, hypertrophic, or restrictive cardiomyopathy; or any other cardiac abnormality that, in the opinion of the investigator, medical monitor, or consultant cardiologist, may place the subject at an unacceptably increased risk with study drug
    6. History of any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, atrial fibrillation, cardiac arrest, Mobitz II second degree heart block, or third degree heart block; QTc at Screening > 450 ms in males / > 470 ms in females; family history of short QT syndrome, long QT syndrome; obligate use of a
    cardiac pacemaker. Use of medications that may cause Torsades de Pointes; any of these medications must be discontinued for at least 5 half-lives prior to the first dose of JNJ-26481585.
    7. Use of potent inhibitors of CYP3A4/A5
    8. Known HIV/AIDS
    9. Uncontrolled concurrent illness including, but not limited to, poorly controlled hypertension or diabetes, ongoing clinically significant active infection requiring systemic antibiotics, or psychiatric illness/social situation that may potentially impair subject’s compliance with study procedures
    10. Planned major surgery during study period
    11. Inadequate gastrointestinal absorption status (status post-gastrectomy, upper gastrointestinal tract obstruction, inability to swallow)
    12. Requires hematopoietic growth factors or transfusion of blood products to meet eligibility criteria
    13. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study, or prevent the subject from meeting or performing study requirements
    14. Pregnant or breast-feeding
    NOTE: Investigators should ensure that all study enrollment criteria have been met at Screening. If a subject's status changes (including laboratory results) after Screening but before first dose of study drug is given such that they now meet an exclusion criterion, they should be excluded from participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Number of participants who will achieve overall cutaneous Response Rate (RR) based on modified Severity Weighted Assessment Tool (mSWAT) criteria

    E.5.1.1Timepoint(s) of evaluation of this end point
    From screening until progressive disease or confirmed lost to follow-up or death or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant
    E.5.2Secondary end point(s)
    1.Number of participants who will achieve global Response Rate (RR) based on based on consensus global response score.
    2.Progression-Free Survival (PFS)
    3.Kaplan-Meier Estimates of 1-year overall survival (OS) rate
    4.Duration of response (DOR) for participants achieving Complete Response (CR) or Partial Response (PR)
    5.The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
    6.Pruritus Intensity Assessment Questionnaire scale scores
    7.Number of participants with adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.From screening until progressive disease or confirmed lost to follow-up or death from any cause or start of alternate therapy, or withdrawal from the study; as assessed for approximately 6 months after the enrollment of the last participant.
    2.From the date of administration of the first dose of study medication until progressive disease or death from any cause, whichever occurs first; as assessed for approximately 6 months after the enrollment of the last participant
    3.From the date of administration of the first dose of study
    medication up to the date of progressive disease or death, whichever occurs first; as assessed up to 1 year

    The timepoints for evaluation of endpoint 4, 5, 6 and 7 is not included due to maximum character count.
    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
    Exploratory Biomarkers Evaluations
    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 Yes
    E.8.1.7.1Other trial design description
    Single-Arm
    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 trial1
    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 concerned2
    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
    France
    Germany
    Italy
    Portugal
    Spain
    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
    The Study is considered completed with the last study assessment for the last subject participating in the study.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 13
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 23
    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)
    Subjects may enter a Long-term Extension Phase and continue to receive study treatment until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective drugs that the subject may receive, or treating physician advice). The Long-term Extension Phase will continue for a maximum of 2 years beyond the clinical cut-off for primary analysis.
    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 Decision2011-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-22
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