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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-003016-35
    Sponsor's Protocol Code Number:CLBH589E2214
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-003016-35
    A.3Full title of the trial
    A Phase II Study of Oral Panobinostat in Adult Patients with
    Relapsed/Refractory Classical Hodgkin’s Lymphoma after high-dose chemotherapy with autologous stem cell transplant
    A.4.1Sponsor's protocol code numberCLBH589E2214
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressForum 1, Novartis Campus
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number41613241111
    B.5.5Fax number41613248001
    B.5.6E-mailclinicaltrial.enquiries@novartis.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 namepanobinostat
    D.3.2Product code LBH589E
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpanobinostat
    D.3.9.1CAS number 404950-80-7
    D.3.9.2Current sponsor codeLBH589E
    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 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.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.3.1Product namepanobinostat
    D.3.2Product code LBH589E
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpanobinostat
    D.3.9.1CAS number 404950-80-7
    D.3.9.2Current sponsor codeLBH589E
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsed/refractory classical Hodgkin's lymphoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10020328
    E.1.2Term Hodgkin's lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the objective response rate to therapy with oral
    panobinostat in patients with refractory/relapsed classical HL using
    modified response criteria for malignant lymphoma (see Post-text
    supplement 1).
    E.2.2Secondary objectives of the trial
    • To determine response rate based on central review of CT scan/MRI
    • To assess the time to response
    • To assess the duration of response
    • To evaluate progression-free survival, PFS rate at 6 month and 8
    month
    • To assess the safety and tolerability of panobinostat treatment
    • To assess overall survival
    • To characterize the PK of panobinostat, including the parent drug
    and any potential metabolite/s when feasible in at least 15
    consenting patients with HL
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient age is ≥ 18 years
    2. Patient has an Eastern Cooperative Oncology Group (ECOG)
    performance status of ≤ 2
    3. Patient has a history of classical HL (i.e. Nodular sclerosing, Mixedcellularity,
    Lymphocyte-rich, Lymphocyte depleted)
    4. Patient has progressive disease after receiving high dose
    chemotherapy with AHSCT.
    Note: If last therapy was ≥ 18 months ago, then a biopsy should be performed to confirm diagnosis.
    Note: Patient should have received <=5 prior systemic treatment regimens (See PTS 2 for definitions and examples)
    5. Patient has at least one site of measurable nodal disease at baseline
    ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan
    (MRI is allowed only if CT scan can not be performed).
    Note: Patients with bone marrow involvement are eligible, but this
    criteria alone should not be used for disease measurement.
    6. Patient has the following laboratory values (labs may be repeated, if
    needed, to obtain acceptable values before screen fail):
    • Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L [SI units 1.5 x
    109/L]
    • Platelet count ≥ 75 x 109/L
    • Serum potassium, magnesium, phosphorus, sodium, total calcium
    (corrected for serum albumin) or ionized calcium within normal
    limits (WNL) for the institution
    Note: Potassium, calcium, magnesium, sodium, and/or phosphorus
    supplements may be given to correct values that are <LLN. Postcorrection
    values must not be deemed to be a clinically significant
    abnormality prior to patients being dosed.
    • Serum creatinine ≤ 1.5 x ULN
    • Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert
    syndrome)
    • AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN)
    or ≤ 5.0 x ULN if the transaminase elevation is due to disease
    involvement
    7. Clinically euthyroid
    Note: Patients are permitted to receive thyroid hormone supplements
    to treat underlying hypothyroidism.
    8. Written informed consent was obtained from the patient prior to any
    study-specific screening procedures
    9. Patient has the ability to swallow capsules or tablets
    E.4Principal exclusion criteria
    1. Patient has a history of prior treatment with a DAC inhibitor including
    panobinostat
    2. Patient will need valproic acid for any medical condition during the
    study or within 5 days prior to the first panobinostat treatment
    3. Patient has been treated with monoclonal antibody therapy (e.g.,
    rituximab or anti CD-30 antibody, etc.) within 4 weeks of start of
    study treatment
    4. Patient has received chemotherapy or any investigational drug or
    undergone major surgery ≤ 2 weeks prior to starting study drug or
    whose side effects of such therapy have not resolved to ≤ grade 1
    5. Patient has been treated with > 5 prior systemic lines of treatment
    (see Post-text supplement 2 for definitions and examples)
    6. Patient has received prior radiation therapy ≤ 4 weeks or limited field
    radiotherapy ≤ 2 weeks prior to start of study treatment or whose
    side effects of such therapy have not resolved to ≤ grade 1
    7. Patient is using any anti-cancer therapy concomitantly
    8. Patient has been treated with allogeneic hematopoietic stem cell
    transplant who isq currently on, or has received immunosuppressive therapy within 90
    days prior to start of screening and/or have ≥ Grade 2 graft versus host disease (GvHD).
    9. Patient has a history of another primary malignancy ≤ 3 years before
    study entry, with the exception of non-melanoma skin cancer, and
    carcinoma in situ of uterine cervix
    10. Patient has a history of CNS involvement with lymphoma
    11. Patient has impaired cardiac function including any of the following:
    • Complete left bundle branch block or use of a permanent cardiac
    pacemaker, congenital long QT syndrome, history or presence of
    ventricular tachyarrhythmias, clinically significant resting
    bradycardia (<50 beats per minute), QTcF > 450 msec on
    screening ECG, or right bundle branch block + left anterior
    hemiblock (bifascicular block)
    • Presence of unstable atrial fibrillation (ventricular heart rate >100
    bpm). Patients with stable atrial fibrillation are allowed in the study
    provided they do not meet the other cardiac exclusion criteria
    • Previous history angina pectoris or acute MI within 6 months
    • Congestive heart failure (New York Heart Association functional
    classification III-IV)
    12. Patient has any other clinically significant heart disease (e.g.,
    uncontrolled hypertension)
    13. Patient has an impairment of gastrointestinal (GI) function or GI
    disease that may significantly alter the absorption of panobinostat
    (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea,
    malabsorption syndrome, obstruction, or stomach and/or small bowel
    resection)
    14. Patient has unresolved diarrhea ≥ grade 2
    15. Patient has any other concurrent severe and/or uncontrolled medical
    condition(s) (e.g., uncontrolled diabetes mellitus, active or
    uncontrolled infection, chronic obstructive or chronic restrictive
    pulmonary disease including dyspnoea at rest from any cause) that
    could cause unacceptable safety risks or compromise compliance
    with the protocol
    16. Patient has a known history of HIV seropositivity (screening HIV
    testing is not required)
    17. Patient is using medications that have a relative risk of prolonging
    the QT interval or of inducing Torsade de Pointes, where such
    treatment cannot be discontinued or switched to a different
    medication prior to starting study drug
    18. Women who are pregnant or breast feeding or women of
    childbearing potential (WOCBP) not willing to use a double method
    of contraception during the study and 3 months after the end of
    treatment. One of these methods of contraception must be a barrier
    method. WOCBP are defined as sexually mature women who have
    not undergone a hysterectomy or who have not been naturally
    postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
    WOCBP must have a negative serum pregnancy test at baseline.
    19. Male patient whose sexual partner(s) are WOCBP who are not
    willing to use a double method of contraception, one of which
    includes a condom, during the study and for 3 months after the end
    of treatment
    E.5 End points
    E.5.1Primary end point(s)
    CT scan to assess the response rate and for monitoring for progression
    safety
    pharmacokinetic parameters: Cmax, Tmax, and AUC0-24
    Exploratory FDG-PET scan response and exploratory biomarkers
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    biomarker assessment
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    see protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days22
    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 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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 102
    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
    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 Decision2008-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-12-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-12
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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