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    Summary
    EudraCT Number:2013-004008-20
    Sponsor's Protocol Code Number:IPI-145-06
    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:2014-07-04
    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 number2013-004008-20
    A.3Full title of the trial
    A Phase 2 Study of IPI-145 in Subjects with Refractory Indolent Non-Hodgkin Lymphoma.
    Estudio de Fase 2 de IPI-145 en sujetos con Linfoma no Hodgkin indolente refractario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety and tolerability of IPI-145 in subjects diagnosed with indolent Non-Hodgkin Lymphoma.
    Eficacia, seguridad y tolerabilidad de IPI-145 en sujetos diagnosticados con Linfoma no Hodgkin indolente.
    A.4.1Sponsor's protocol code numberIPI-145-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01882803
    A.5.4Other Identifiers
    Name:INDNumber:112,486
    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 SponsorInfinity 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 supportInfinity Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (Spain), S.L.U.
    B.5.2Functional name of contact pointDepartamento Asuntos Regulatorios
    B.5.3 Address:
    B.5.3.1Street AddressC/ Antracita, 7 - Planta 1 - Nave 6
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28045
    B.5.3.4CountrySpain
    B.5.4Telephone number+34911459110
    B.5.5Fax number+34914342773
    B.5.6E-mailIPI-145-06@infi.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 numberEMA/OD/047/13
    D.3 Description of the IMP
    D.3.1Product nameIPI-145
    D.3.2Product code IPI-145
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot available yet
    D.3.9.1CAS number 1386861-49-9
    D.3.9.2Current sponsor codeIPI-145
    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) 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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/047/13
    D.3 Description of the IMP
    D.3.1Product nameIPI-145
    D.3.2Product code IPI-145
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNot available yet
    D.3.9.1CAS number 1386861-49-9
    D.3.9.2Current sponsor codeIPI-145
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Refractory Indolent Non-Hodgkin Lymphoma
    Linfoma no Hodgkin indolente refractario
    E.1.1.1Medical condition in easily understood language
    indolent Non-Hodgkin's Lymphoma (iNHL)
    Linfoma no Hodgkin indolente (LNHi)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10029627
    E.1.2Term Non-Hodgkin's lymphoma unspecified histology intermediate grade refractory
    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 evaluate the antitumor activity of IPI-145 administered to subjects diagnosed with indolent non-Hodgkin lymphoma (iNHL) (defined as follicular lymphoma [FL], marginal zone lymphoma [MZL; splenic, nodal and extranodal], or small lymphocytic lymphoma [SLL]) whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).
    Evaluar la actividad antitumoral de IPI-145 administrado a sujetos diagnosticados de linfoma no Hodgkin indolente (LNHi) (definido como linfoma folicular [LF], linfoma de la zona marginal [LZM; esplénico, ganglionar o extraganglionar] o linfoma linfocítico de célula pequeña [LLP]) con enfermedad refractaria a rituximab y a la quimioterapia o radioinmunoterapia (RIT).
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    .To evaluate the safety of IPI-145 in all subjects
    .To evaluate additional efficacy parameters in all subjects
    .To evaluate the pharmacokinetics (PK) of IPI-145 and, if applicable, its metabolite(s)
    Objetivos secundarios:
    . Evaluar la seguridad de IPI-145 en todos los sujetos.
    . Evaluar otros parámetros de la eficacia en todos los sujetos.
    . Evaluar la farmacocinética (FC) de IPI-145 y, si procede, sus metabolitos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    .Subjects who have been diagnosed with indolent NHL that has progressed.
    .Subjects must have exhibited no response or progression within 6 months after the last dose of a chemotherapy induction regimen or RIT.
    .Subjects must have rituximab-refractory disease.
    .Measurable disease with a lymph node or tumor mass >or= 1.5 cm in at least one dimension by CT.
    .Adequate renal and hepatic function.
    . Sujetos con diagnóstico de LNH indolente con progresión.
    . Los sujetos no deben haber presentado ninguna respuesta o progresión dentro de los 6 meses después de la última dosis de un régimen de inducción de quimioterapia o RIT.
    . Los sujetos con enfermedad refractaria a rituximab.
    . Enfermedad mensurable con un ganglio linfático o masa tumoral >o= 1,5 cm en al menos una dimensión mediante TC.
    . Función renal y hepática adecuada
    E.4Principal exclusion criteria
    .Candidate for potentially curative therapies in the opinion of the investigator.
    .Previous treatment with any PI3K inhibitor or BTK inhibitor.
    .Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
    .Prior chemotherapy, cancer immunosuppressive therapy, or other investigational agents within 4 weeks before first dose of study drug.
    .Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
    .Symptomatic central nervous system (CNS) NHL.
    .Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
    . Candidatos a otros tratamientos potencialmente curativos en opinión del investigador.
    . Tratamiento previo con inhibidores de PI3K o inhibidores de la BTK
    . Antecedentes de alotrasplante de células madre hematopoyéticas (TCPH).
    . Tratamiento previo con quimioterapia, terapia oncológica con inmunodepresores u otros fármacos en investigación en las 4 semanas previas a la primera dosis del fármaco del estudio.
    . LF de grado 3B o evidencia clínica de transformación a un subtipo de linfoma más agresivo.
    . LNH del sistema nervioso central (SNC) sintomático
    . Infecciones bacterianas, micóticas o víricas sistémicas en curso en el momento de iniciar el tratamiento del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR), with overall response defined as best response of complete response/remission (CR) or partial response/remission (PR) according to the revised International Working Group (IWG) Criteria
    La tasa de respuestas globales (TRG), tomando como definición de respuesta global la mejor respuesta de respuesta/remisión completa (RC) o respuesta/remisión parcial (RP), conforme a los criterios revisados del Grupo de trabajo internacional (IWG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT scans of chest, abdomen and pelvis & focused physical examination and assessment of B symptoms & response assessment: screening, Day -7 to Day 1 of Cycles 3, 5, 7, 10, 14, 18 and every 4th cycle thereafter, end of treatment
    Bone marrow biopsy and bone marrow aspiration: screening, Day -7 to Day 1 of Cycles 3, 5, 7, 10, 14, 18 and every 4th cycle thereafter
    Las TC de tórax, abdomen y pelvis así como exploración física orientada y evaluación de los síntomas B y evaluación de la respuesta: selección, Día -7 a Día 1 de los Ciclos 3, 5, 7, 10, 14, 18 y a cada cuarto ciclo a partir de entonces hasta el final del tratamiento.
    Biopsia de médula ósea y aspiración de médula ósea: selección, Día -7 a Día 1 de los Ciclos 3,5, 7, 10, 14, 18 y cada cuarto ciclo a partir de entonces
    E.5.2Secondary end point(s)
    Secondary endpoints:
    .Treatment-emergent adverse events (TEAEs), ECG measures, and changes in safety laboratory values
    .Duration of response (DOR), defined as the time from the first documentation of response to the first documentation of progressive disease (PD) or death due to any cause
    .Progression-free survival (PFS)
    .Overall survival (OS)
    .Time to response (TTR)
    .PK parameters derived from plasma IPI-145 concentrations and, if applicable, its metabolite(s)
    Criterios de valoración secundarios:
    . Acontecimientos adversos de aparición durante el tratamiento (AAAT), determinaciones del ECG y modificaciones en los valores analíticos de seguridad.
    . Duración de la respuesta (DR), definida como el tiempo transcurrido entre la primera documentación de respuesta y la primera documentación de progresión de la enfermedad (PE) o la muerte por cualquier causa.
    . Supervivencia sin progresión (SSP)
    . Supervivencia global (SG)
    . Tiempo hasta la respuesta (THR)
    . Parámetros de FC obtenidos a partir de las concentraciones plasmáticas de IPI-145 y, si procede, sus metabolitos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    AE/SAE: screening, cycles 1 (Day 1 & 15) to 8 and beyond (every 2 cycles), end of treatment and 30 days post-treatment
    PK blood sample collection: Day 15 of Cycle 1, Day 1 of Cycles 2 and 3
    ECG: Day 1 and 15 of Cycle 1
    AA/AAG: selecc., ciclos 1 (Día 1 & 15) a 8 y post (cada 2 ciclos), fin trat y 30 días posterior al trat
    Obtención de la muestra de sangre para farmacocinética: Día 15 del ciclo 1, Día 1 de los ciclos 2 y 3
    ECG: Días 1 y 15 del Ciclo 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Belarus
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Georgia
    Hungary
    Italy
    Spain
    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
    Last survival follow-up visit/communication for the last patient.. Subjects will be followed for survival for up to 3 years after their first dose of IPI-145. The maximum number of months to complete the study is expected to be approximately 54 months.
    Última visita de seguimiento de supervivencia/ comunicación del último paciente. Se realizará un seguimiento de la supervivencia de los sujetos durante un máximo de 3 años a partir de la administración de la primera dosis de IPI-145. Se prevé que el tiempo máximo para completar el estudio será de aproximadamente 54 meses.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 120
    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)
    After completing 13 treatment cycles of IPI-145, subjects who, in the judgment of the investigator, may derive benefit from continued treatment, may continue to receive additional cycles of IPI-145 for up to a total of 2 years of treatment. However, to receive additional cycles of IPI-145 beyond 13 cycles, subjects must have evidence of response (CR or PR) according to the IWG criteria 1 by the start of cycle 14, day 1.
    Después de cumplir los 13 ciclos de tratamiento del IPI-145, los pacientes que a jucio del investigador podrían beneficiarse de continuar con el tratamiento, pueden recibir ciclos adicionales del IP-145 por un periodo total de dos años de tratamiento. Sin embargo para recibir ciclos adicionales del IP-145 después de los 13 ciclos, los pacientes deberán haber mostrado evidencias de respuesta (RCo RP) de acuerdo con el IWG criterio 1 al inicio del ciclo 14, día 1.
    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 Decision2014-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
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