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    Summary
    EudraCT Number:2015-000206-18
    Sponsor's Protocol Code Number:PM1183-B-005-14-QT
    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:2015-07-10
    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 number2015-000206-18
    A.3Full title of the trial
    Evaluation of the Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Selected Solid Tumors
    Evaluación del efecto de lurbinectedina (PM01183) en la repolarización cardiaca (duración del intervalo QTc) en pacientes con tumores sólidos seleccionados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Lurbinectedin (PM01183) on Cardiac Repolarization (QTc Duration) in Patients with Solid Tumors
    Efecto de lurbinectedina (PM01183) en la repolarización cardiaca (duración del intervalo QTc) en pacientes con tumores sólidos
    A.4.1Sponsor's protocol code numberPM1183-B-005-14-QT
    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 SponsorPharmaMar S.A., Sociedad Unipersonal
    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 supportPharma Mar, S.A. Sociedad Unipersonal
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A. Sociedad Unipersonal
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAv. de Los Reyes nº 1, Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo ( Madrid)
    B.5.3.3Post code28770
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491846 60 87
    B.5.5Fax number+3491846 60 03
    B.5.6E-mailclinicaltrials@pharmamar.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 nameLurbinectedin 4 mg powder for concentrate for solution for infusion
    D.3.2Product code PM01183
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlurbinectedin
    D.3.9.1CAS number 497871-47-3
    D.3.9.2Current sponsor codePM01183
    D.3.9.4EV Substance CodeSUB31196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    - small cell lung cancer (SCLC)
    - head and neck carcinoma (H&N)
    - neuroendocrine tumors (NETs)
    - biliary tract carcinoma
    - endometrial carcinoma
    - BRCA 1/2-associated metastatic breast carcinoma
    - carcinoma of unknown primary site
    - germ cell tumors (GCTs)
    - Ewing?s family of tumors (EFTs)
    - carcinoma microcítico pulmonar (CMP)
    - carcinoma de cabeza y cuello (CyC)
    - tumores neuroendocrinos (TNE)
    - carcinoma de vías biliares
    - carcinoma endometrial
    - carcinoma de mama metastásico asociado a BRCA 1/2
    - carcinoma de origen primario desconocido
    - tumores de células germinales (TCG)
    - familia de tumores de Ewing (FTE).
    E.1.1.1Medical condition in easily understood language
    Cancer of lung, head & neck, breast, neuroendocrine tumors, biliary carcinoma, endometrial carcinoma, carcinoma of unknown primary site, germ cell tumors and Ewing tumors
    Cáncer de pulmón, cabeza y cuello, mama, neuroendocrino, cáncer de vesícula biliar, cáncer de endometrio, cáncer con origen primario desconocido, tumores de células germinales y tumores de Ewing.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10048683
    E.1.2Term Advanced cancer
    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
    To assess the potential effects of PM01183 at a therapeutic dose on the duration of the QTc interval, measured by electrocardiograms (ECGs), in patients with selected solid tumors.
    Evaluar los efectos potenciales de PM01183 a una dosis terapéutica sobre la duración del intervalo QTc, determinado mediante electrocardiogramas (ECG), en pacientes con tumores sólidos seleccionados
    E.2.2Secondary objectives of the trial
    - To characterize the PM01183 plasma concentration/QTc relationship
    - To explore related ECG parameters
    - Caracterizar la relación del intervalo QTc/concentración plasmática de PM01183
    - Analizar los parámetros de ECG relacionados.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) To be enrolled in clinical trial PM1183-B-005-14
    2) Voluntarily signed and dated informed consent to participate in this QT evaluation study
    3) Qualifying 12-lead ECG (between Day -10 and Day -2 before first IMP administration) consistent with normal cardiac conduction and function, that will be read by the central laboratory, showing:
    a) Sinus rhythm.
    b) Heart rate between 45 and 100 beats per min (bpm).
    c) QTcF ? 500 ms.
    d) QRS interval <110 ms.
    e) PR interval <220 ms.
    4) Blood pressure between 90 and 150 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic
    5) Serum electrolyte levels within ten days prior to the first infusion ? grade 1 [National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.4.0]:
    a) Corrected serum Ca: 2.0 ? 2.9 mmol/l.*
    b) K: 3 ? 5.5 mmol/l. **
    c) Mg: 0.5 ? 1.23 mmol/l.
    * Corrected serum Ca for albumin = Measured serum Ca (mmol/l) + 0.2 * [4.0
    ? Measured albumin (g/dl)].
    ** Patients with K < 4 mmol/l could have their potassium repleted to allow
    them to participate. If so, K should be re-tested to confirm that new levels of
    serum K are within the specified range.
    1) Ser participante del ensayo clínico PM1183-B-005-14
    2) Consentimiento informado (CI) del paciente firmado y fechado voluntariamente para participar en este estudio de evaluación del intervalo QT
    3) ECG de 12 derivaciones de selección (entre los días -10 y -2 antes de la primera administración del MI) consistente con una función y conducción cardiaca normal, cuya revisión correrá a cargo del laboratorio central, que muestre:
    a) Ritmo sinusal.
    b) Frecuencia cardiaca entre 45 y 100 latidos por min (lpm).
    c) QTcF ? 500 ms.
    d) Intervalo QRS < 110 ms.
    e) Intervalo PR < 220 ms.
    4) Tensión arterial sistólica entre 90 y 150 mmHg , inclusive, y diastólica no superior a 90 mmHg
    5) Niveles de electrolitos séricos en los diez días previos a la primera perfusión de grado ? 1 [criterios terminológicos comunes de acontecimientos adversos del Instituto Nacional del Cáncer (NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events) v.4.0]:
    a) Ca en suero corregido: 2,0 ? 2,9 mmol/l*.
    b) K: 3 ? 5,5 mmol/l**.
    c) Mg: 0,5 ? 1,23 mmol/l.
    * Ca en suero corregido para albúmina = Ca medido en suero (mmol/l) + 0,2* [4,0 ? albúmina medida (g/dl)].
    **Los pacientes con K < 4 mmol/l podrían completar su nivel de potasio para poder participar. En ese caso, se debe volver a medir la concentración de K para confirmar que los nuevos valores de K sérico se encuentran entre el intervalo especificado
    E.4Principal exclusion criteria
    1) Age > 65 years
    2) Eastern Cooperative Oncology Group performance status (ECOG PS) = 2 *
    3) Heart rhythm disturbances (e.g., atrial fibrillation), unusual T wave and U wave (if present) morphology, personal or family history of Long QT Syndrome, complete left bundle branch block, permanent ventricular pacemaker, or Brugada Syndrome
    4) Significant ischemic coronary disease, New York Heart Association (NYHA) class III or IV congestive heart failure, myocardial infarction, or unstable angina within the last six months
    5) Any skin condition likely to interfere with ECG electrode placement, or history of breast implant or thoracic surgery likely to cause abnormality in electrical conduction
    6) Prior exposure to anthracyclines at a cumulative dose of doxorubicin (or equivalent) > 450 mg/m²
    7) Patients who are at screening on QT-prolonging medication (rated as 1 at APPENDIX 1: Lists of drugs that prolong the QT interval and/or induce torsades de pointes ventricular arrhythmia), if it cannot be interrupted at least 48 hours before each ECG assessment
    * Note that PM1183-B-005-14 eligibility criteria permit ECOG PS ? 2.
    1) Edad > 65 años
    2) Estado funcional del Eastern Cooperative Oncology Group (EF ECOG) = 2*
    3) Trastornos del ritmo cardiaco (p.ej., fibrilación auricular), morfología inusual de las ondas T y U (si estuvieran presentes), antecedentes personales o familiares de síndrome del intervalo QT largo, hemibloqueo ventricular izquierdo completo, marcapasos ventricular permanente o síndrome de Brugada
    4) Enfermedad coronaria isquémica significativa, insuficiencia cardiaca congestiva de clase III o IV según la Asociación del corazón de Nueva York (NYHA, New York Heart Association), infarto de miocardio o angina inestable en los últimos seis meses
    5) Cualquier afección cutánea con probabilidad de interferir con la colocación de los electrodos del ECG o antecedentes de implante mamario o cirugía torácica que pueden producir anomalías en la conducción eléctrica
    6) Exposición previa a antraciclinas a una dosis acumulada de doxorrubicina (o equivalente) > 450 mg/m²
    7) Pacientes que, en la selección, reciban un tratamiento que prolonga el intervalo QT (clasificado como 1 en el APÉNDICE 1), si no puede interrumpirse un mínimo de 48 horas antes de cada valoración del ECG.
    *A destacar que los criterios de elegibilidad de PM1183-B-005-14 permiten un EF ECOG ? 2
    E.5 End points
    E.5.1Primary end point(s)
    Change in QTcF: Difference in QT corrected by Fridericia?s method (QTcF) between each scheduled post-dose ECG time point and baseline at Cycle 1 (?QTcF)
    Cambios en el segmento QTcF: Diferencia en el segmento QT corregido con la fórmula de Fridericia (?QTcF) entre cada ECG post-dosis y el valor basal del ciclo 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo del ensayo clínico
    E.5.2Secondary end point(s)
    - Relationship ?QTcF / PM01183 plasma concentration: concentration-effect relationship for PM01183 will be evaluated
    - Change in other ECG parameters: changes in response rate (RR), heart rate,QRS, and PR will be explored
    - Relatión entre el incremento de QTcF / concentración plasmática de PM01183.
    - Análisis de los cambios en otros parámetros del ECG: cambios en la tasa de respuesta, ritmo cardiaco, segmento QRS y segmento PR
    E.5.2.1Timepoint(s) of evaluation of this end point
    Along the study
    A lo largo del ensayo clínico
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 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 No
    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.8.3 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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    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 end of study for the QT evaluation study will be 30 days after the last ECG is performed.
    El final del estudio de evaluación del intervalo QT será 30 días después de obtener el último ECG.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.1.1In 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: 25
    F.1.3Elderly (>=65 years) No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 25
    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)
    none
    ninguno
    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 Decision2015-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-19
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