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    Summary
    EudraCT Number:2008-002983-32
    Sponsor's Protocol Code Number:CLBH589B2213
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-05
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-002983-32
    A.3Full title of the trial
    Estudio Fase II de Panobinostat oral en monoterapia, en pacientes con leucemia mieloide aguda (LMA) refractaria de novo o refractaria secundaria.
    A.4.1Sponsor's protocol code numberCLBH589B2213
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 namepanobinostat
    D.3.2Product code LBH589
    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 codeLBH589
    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 LBH589
    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 codeLBH589
    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
    Pacientes con leucemia mieloide aguda (LMA) refractaria de novo o refractaria secundaria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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 complete remission rate (CRR, defined as CR + CRi).
    E.2.2Secondary objectives of the trial
    • To assess partial response.
    • To assess time to and duration of remission.
    • To assess overall and event-free survival.
    • To assess safety and tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    5.1.1 Stratum A Specific Inclusion Criterion
    1. Refractory AML with confirmed initial diagnosis of de novo AML (excluding APL)
    5.1.2 Stratum B Specific Inclusion Criterion
    1. Refractory AML with confirmed initial diagnosis of AML (excluding APL) secondary to AHD or MDS with either condition precedent to AML (MDS/AHD) having received either no treatment or conventional care regimens (CCR), including best supportive care (BSC), low dose cytarabine, intensive chemotherapy, hypomethylating agents (azacitidine, decitabine), or other therapies (e.g. lenalidomide)
    5.1.3 Stratum A or B General Inclusion Criteria
    1. Written informed consent prior to study-specific screening procedures
    2. Age &#8805; 18 years old
    3. Refractory AML, defined as no response (CR1) to initial induction treatment or CR1 lasting <12 months and in first relapse
    4. Eastern Cooperative Group (ECOG) performance status &#8804; 2
    5. Laboratory values as follows:
    • Electrolyte panel WNL for the institution (potassium and magnesium values < lower limit of normal must be corrected to WNL prior to dosing)
    • Total calsium (corrected for albumin) or ionized calcium WNL for the institution
    • AST/SGOT and ALT/SGPT &#8804; 2.5 x ULN (NCI CTCAE Gr 1)
    • Serum creatinine &#8804; 1.5 x ULN (NCI CTCAE Gr 1)
    • Serum bilirubin &#8804; 1.5 x ULN unless attributed to underlying disease (NCI CTCAE Gr 1)
    • INR &#8804; 1.5 and PTT WNL. Patients receiving anticoagulation therapy (e.g. coumadin, heparin) are eligible provided anticoagulation therapy can be discontinued or changed to parenteral medications while the platelet count is less than 50,000/mm3
    • Negative serum pregnancy test (within 7 days of first dose)
    • Negative urine pregnancy test immediately prior to first dose
    • Clinically euthyroid (hypothyroidism corrected with supplementation is permitted)
    6. Patient has received remission induction therapy (± consolidation) for AML, including chemotherapy and/or HSCT.
    7. Previous chemotherapy for AML has stopped at least 2 weeks or at least five half lives, whichever is longer, before the first dose of study drug
    8. Patient has recovered from toxicity of previous antileukemic therapy, including Grade &#8804; 1 non-hematologic toxicity prior to the first dose of study drug
    E.4Principal exclusion criteria
    5.1.4 Stratum A or B General Exclusion Criteria
    1. Patients with initial diagnosis of AML secondary to ionizing radiation/cytotoxic therapy (e.g. alkylating agents) for previous malignancy
    2. Patients requiring valproic acid for any medical condition during the study or within 5 days prior to the first dose of study drug
    3. Clinical symptoms suggesting CNS leukemia (patients with neurologic symptoms must undergo lumbar puncture and a CT scan or MRI of the brain to exclude CNS involvement
    4. Patients receiving supportive therapy related to complications of allogeneic transplantation, including infections or GVH directed therapy
    5. Patients who have received either hydroxyurea or glucocorticosteroids for prevention of leukostasis less than 24 hours before the fist dose of study drug
    6. Patients with another malignancy (with the exception of prior MDS in patients with initial diagnosis of AML secondary to MDS/AHD) unless disease-free for at least 3 years following the completion of curative intent therapy. Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasm regardless of the disease-free duration, are eligible if definitive treatment for the condition has been completed.
    7. Patients with 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 &#8805; 450 ms on screening ECG, or right bundle branch block + left anterior hemiblock (bifascicular block)
    • LVEF< lower limit of institutional normal, as assessed by ECHO or MUGA
    • Presence of unstable atrial fibrillation (ventricular response rate >100 bpm). Patients with stable atrial fibrillation are eligible provided they do not meet the other cardiac exclusion criteria
    • Angina pectoris or acute MI within 6 months
    • Other clinically significant heart disease (e.g. uncontrolled hypertension or history of poor compliance with an antihypertensive regimen)
    8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes mellitus, chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause) or history of serious organ dysfunction or disease involving the heart, kidney or liver and/or known seropositive HIV (HIV screening testing is not required)
    9. Patient has an impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral panobinostat (e.g., ulcerative disease, uncontrolled vomiting, grade > 1 diarrhea, malabsorption syndrome, obstruction, or stomach and/or small bowel resection)
    10. Psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
    11. Concurrent use of medications that have a relative risk of prolonging the QT interval or of inducing Torsade de Pointes, if such treatment cannot be discontinued or switched to a different medication prior to the first dose of study drug
    12. Female patients who are pregnant or breast-feeding or patients of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been postmenopausal for at least 12 consecutive months (i.e. has had menses any time in the preceding 12 consecutive months).
    13. Male patients whose sexual partner(s) are women of childbearing potential (WOCBP) who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment.
    14. Patient is receiving concurrent immuno, gene, or biologic therapy
    15. Patient is unable to swallow capsules
    E.5 End points
    E.5.1Primary end point(s)
    • Complete remission rate (CRR), defined as the number of CR/CRi in patients with refractory de novo AML (Stratum A) or refractory secondary AML (Stratum B). CR and CRi will be assessed by the Investigator according to the response criteria for AML (Cheson, et al 2003) as implemented in the Post-test supplement 1.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad
    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 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.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 164
    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 Decision2009-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-20
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