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    Summary
    EudraCT Number:2010-018893-19
    Sponsor's Protocol Code Number:Perifosine339
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-04-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-018893-19
    A.3Full title of the trial
    A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma
    Patients Previously Treated with Bortezomib
    Estudio de fase III, aleatorizado, para evaluar la eficacia y la seguridad de la perifosina añadida a la combinación de bortezomib y dexametasona en pacientes con mieloma múltiple tratados previamente con bortezomib.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate whether perifosine is effective and safe in treating patients with multiple myeloma when combined with bortezomib (Velcade®) and dexamethasone
    Estudio clínico para investigar si perifosina es eficaz y segura en el tratamiento de pacientes con mieloma múltiple combinado con bortezomib (Velcade®) y dexametasona.
    A.4.1Sponsor's protocol code numberPerifosine339
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01002248
    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 SponsorAOI Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportAOI Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAeterna Zentaris GmbH
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressWeismüllerstrasse 50
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60314
    B.5.3.4CountryGermany
    B.5.4Telephone number+4969426023429
    B.5.5Fax number+4969426023404
    B.5.6E-mailclinical.trials@aezs.inc.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/740
    D.3 Description of the IMP
    D.3.1Product namePerifosine
    D.3.2Product code KRX-0401
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.8INN - Proposed INNPERIFOSINE
    D.3.9.1CAS number 157716524
    D.3.9.2Current sponsor codeKRX‐0401
    D.3.9.3Other descriptive nameOctadecylphosphopiperidine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multiple myeloma
    Mieloma múltiple
    E.1.1.1Medical condition in easily understood language
    Multiple myeloma is a cancer of a type of white blood cell called plasma cells
    El mieloma múltiple es un tipo de cáncer de un tipo de células de la sangre.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    Comparison of perifosine to placebo with respect to progression‐free survival (PFS) in relapsed or relapsed/refractory multiple myeloma patients receiving bortezomib and dexamethasone.
    Comparar la perifosina con el placebo en cuanto a la supervivencia sin progresión (SSP) en pacientes con mieloma múltiple o en recidiva/refractario sometidos a tratamiento con bortezomib y dexametasona.
    E.2.2Secondary objectives of the trial
    1) comparison of perifosine to placebo with respect to overall response rate (ORR = partial response [PR] or better), overall survival (OS), and time to progression (TTP) in multiple myeloma patients receiving bortezomib and dexamethasone

    2) Evaluation of the safety of the combination of perifosine, bortezomib, and dexamethasone compared to placebo, bortezomib, and dexamethasone.
    1) Comparar la perifosina con el placebo en cuanto a la tasa de respuesta global (TRG = respuesta parcial [RP] o mejor), la supervivencia global (SG) y el tiempo hasta la progresión (THP) en pacientes con mieloma múltiple sometidos a tratamiento con bortezomib y dexametasona;

    2) Evaluar la seguridad de la combinación de perifosina, bortezomib y dexametasona en comparación con placebo, bortezomib y dexametasona.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients with a confirmed diagnosis of relapsed or relapsed/refractory multiple myeloma that are currently progressing or have recently relapsed.

    • Measurable disease (serum M‐protein >0.5g/dl and/or >200mg urinary M‐protein excretion).

    • Patients must have relapsed (progressed > 60 days) after their last dose of bortezomib based therapy. In addition, patients may be refractory to (progressing on or within 60 days of discontinuing therapy) or relapsed from other non‐bortezomib‐based therapies.

    • Patients must have previously received at least two cycles of either single agent bortezomib treatment (21 day cycle) at the 1.3 mg/m2 dose or a minimum of 1.0 mg/m2 if used in combination with other active agents or in patients with underlying neuropathy.

    • Patients must have previously received at least one cycle (minimum of 21 days) of an immunomodulatory agent (e.g. thalidomide, lenalidomide). There is no prior minimum dose requirement for a prior immunomodulatory agent.

    • Patients must have received at least two anti‐myeloma drugs (which must include bortezomib and an immunomodulatory agent). Patients may have received one prior anti‐myeloma regimen which is required to contain a combination of bortezomib and an immunomodulatory agent. Therefore, patients must have received at least one and no more than four prior anti‐myeloma regimens and have progressive disease after the most recent treatment regimen. (Multiple lines of therapy may be most easily delineated by at least disease stabilization followed by a change in therapy due to progression).

    • Patient must be willing and able to participate in PK sampling.
    • Pacientes con un diagnóstico confirmado de mieloma múltiple en recidiva o en recidiva/refractario que muestren progresión de la enfermedad en la actualidad o que hayan presentado recidiva recientemente.
    • Enfermedad mensurable (proteína M sérica > 0,5 g/dl y/o eliminación urinaria de proteína M > 200 mg).
    • Los pacientes deben haber presentado recidiva (progresión > 60 días) después de su última dosis de tratamiento basado en el bortezomib. Además, los pacientes pueden ser refractarios (progresión de la enfermedad durante el tratamiento o en los 60 días siguientes a su suspensión) o haber presentado recidiva tras otros tratamientos no basados en el bortezomib.
    • Los pacientes deben haber recibido previamente por lo menos dos ciclos de bortezomib (ciclo de 21 días) en dosis de 1,3 mg/m2 en monoterapia, o un mínimo de 1,0 mg/m2 si se ha utilizado en combinación con otros agentes activos o en pacientes con neuropatía subyacente.
    • Los pacientes deben haber recibido previamente por lo menos un ciclo (mínimo de 21 días) de un inmunomodulador (por ejemplo, talidomida, lenalidomida). No hay requisito de dosis mínima del inmunomodulador previo.
    • Los pacientes deben haber recibido por lo menos dos tratamientos antimielomatosos (que deben incluir bortezomib y un inmunomodulador). Pueden haber recibido un régimen antimielomatoso previo que debe haber contenido necesariamente una combinación de bortezomib y un inmunomodulador. Por tanto, los pacientes deben haber recibido por lo menos uno y no más de cuatro regímenes antimielomatosos y presentar enfermedad progresiva después del régimen de tratamiento más reciente. (Varias líneas de tratamiento se definirían con mayor facilidad mediante un mínimo de estabilización de la enfermedad seguida de un cambio del tratamiento por progresión.)
    • El paciente debe ser capaz y estar dispuesto a participar en la obtención de muestras para farmacocinética.
    E.4Principal exclusion criteria
    • Patients refractory to any regimen containing bortezomib.

    • Patients with non‐secretory multiple myeloma. (myeloma where the malignant plasma cells do not secrete M protein or light chains).

    • History of allergic reactions or intolerance attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine), bortezomib or dexamethasone or any of their components.

    • Prior treatment with perifosine or an investigational proteasome inhibitor.

    • Chemotherapy or other therapy experimental or proven that is or may be active against myeloma within two weeks (14 days) prior to Cycle 1 Day 1.
    • Pacientes refractarios a cualquier régimen que contenga bortezomib.
    • Pacientes con mieloma múltiple no secretor (mieloma cuyos plasmocitos malignos no secretan proteína M ni cadenas ligeras).
    • Antecedentes de reacciones alérgicas o intolerancia atribuidas a compuestos de composición química o biológica similar a la perifosina (miltefosina o edelfosina), bortezomib o dexametasona, o cualquiera de sus componentes.
    • Tratamiento previo con perifosina o un inhibidor proteasómico en investigación.
    • Quimioterapia u otro tratamiento experimental o demostrado, con actividad o posible actividad contra el mieloma, en las dos semanas (14 días) previas al día 1 del ciclo 1.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival.
    Supervivencia libre de progresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The analysis, which is event‐based, will be conducted after approximately 265 randomized patients have progressed or died.
    El análisis, que está basado en los eventos producidos, se realizará aproximadamente después de que 265 pacientes randomizados hayan progresado o fallecido.
    E.5.2Secondary end point(s)
    1. Comparison of perifosine to placebo with respect to an overall response rate (partial response [PR] or better), overall survival, and time to progression (TTP)

    2. Evaluation of the safety of the combination of perifosine, bortezomib, and dexamethasone compared to placebo, bortezomib, and dexamethasone.
    1. Comparación de perifosina con placebo en cuanto a la tasa de respuesta global (TRG=respuesta parcial [RP] o mejor), la supervivencia global y el tiempo hasta la progresión (TTP)
    2. Evaluación de la seguridad de la combinación de perifosina, bortezomib y dexametasona comparado con placebo, bortezomib y dexametasona.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The analysis, which is event‐based, will be conducted after approximately 265 randomized patients have progressed or died.
    El análisis, basado en eventos, se realizará aproximadamente después de que 265 pacientes randomizados hayan progresado o fallecido.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number 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 EEA40
    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
    Australia
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Ireland
    Israel
    Korea, Republic of
    Lithuania
    New Zealand
    Poland
    Russian Federation
    Slovakia
    South Africa
    Spain
    Ukraine
    United Kingdom
    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
    The Core Phase is planned to continue until approximately 265 randomized patients have progressed or died.

    Patients who are still alive and have not withdrawn consent when the study blind is broken may continue into the Extension Phase. If the primary efficacy results
    demonstrate a benefit of perifosine, patients on placebo will be offered perifosine, and patients on perifosine will be entered into the Extension Phase and allowed to continue taking perifosine.
    La fase primaria continuará hasta que se hayan producido aproximadamente 265 acontecimientos.
    Los pacientes que permanezcan vivos y no hayan retirado el consentimiento podrán continuar en la fase de extensión. Si los resultados de eficacia principales demuestran un beneficio de perifosina, a los pacientes tratados con placebo se les ofrecerá perifosina y los pacientes tratados con perifosina podrán continuar recibiendo perifosina en la fase de extensión.
    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 months0
    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 months0
    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.1.1Number of subjects for this age range: 0
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 450
    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)
    Patient will receive best supportive care according to the current medical standards
    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 Decision2011-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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