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    Summary
    EudraCT Number:2017-003571-56
    Sponsor's Protocol Code Number:APX001-201
    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:2018-07-30
    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 number2017-003571-56
    A.3Full title of the trial
    An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Non-Neutropenic Patients with Candidemia, with or without Invasive Candidiasis, Inclusive of Patients with Suspected Resistance to Standard of Care Antifungal Treatment
    Estudio abierto para evaluar la eficacia y seguridad de APX001 en pacientes no neutropénicos con candidemia, con o sin candidiasis invasiva, incluidos pacientes con posible resistencia al tratamiento antifúngico de referencia no neutropénicos con candidemia, con o sin candidiasis invasiva, incluidos pacientes con posible resistencia al tratamiento antifúngico de referencia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Study to Evaluate the Efficacy and Safety of APX001 in Patients with Candidemia with Suspected Resistance to Standard of Care Antifungal Treatment
    Estudio abierto para evaluar la eficacia y seguridad de APX001 en pacientes con candidemia con posible resistencia al tratamiento antifúngico de referencia
    A.4.1Sponsor's protocol code numberAPX001-201
    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 SponsorAmplyx 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 supportAmplyx Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedpace
    B.5.2Functional name of contact pointJacqueline Widmer
    B.5.3 Address:
    B.5.3.1Street Address5375 Medpace Way
    B.5.3.2Town/ cityCincinnati
    B.5.3.3Post codeOH 45227
    B.5.3.4CountryUnited States
    B.5.4Telephone number+151357999111705
    B.5.5Fax number+1513579444
    B.5.6E-mailJ.Widmer@Medpace.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 nameAPX001
    D.3.2Product code APX001
    D.3.4Pharmaceutical form 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 INNAPX001
    D.3.9.1CAS number 2091769-17-2
    D.3.9.2Current sponsor codeAPX001
    D.3.9.3Other descriptive nameAPX001
    D.3.9.4EV Substance CodeSUB182707
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAPX001
    D.3.2Product code APX001
    D.3.4Pharmaceutical form 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 INNAPX001
    D.3.9.1CAS number 2091769-17-2
    D.3.9.2Current sponsor codeAPX001
    D.3.9.3Other descriptive nameAPX001
    D.3.9.4EV Substance CodeSUB182707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 3
    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 nameAPX001
    D.3.2Product code APX001
    D.3.4Pharmaceutical form 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 INNAPX001
    D.3.9.1CAS number 2091769-17-2
    D.3.9.2Current sponsor codeAPX001
    D.3.9.3Other descriptive nameAPX001
    D.3.9.4EV Substance CodeSUB182707
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Treatment of non-neutropenic subjects with candidemia – inclusive of those subjects with suspected or confirmed antifungal-resistant candidemia with or without invasive candidiasis
    Tratamiento de pacientes no neutropénicos con candidemia, incluyendo aquellos pacientes con posible resistencia al tratamiento antifúngico de referencia
    E.1.1.1Medical condition in easily understood language
    Antifungal treatment
    Tratamiento antifúngico
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10060573
    E.1.2Term Candidemia
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy and safety of APX001 for the treatment of adult non-neutropenic patients with candidemia that may include patients with suspected or confirmed resistance to standard of care (SOC) antifungal treatment.
    El objetivo principal de este estudio es evaluar la eficacia y la seguridad de APX001 para el tratamiento de pacientes adultos no neutropénicos con candidemia, que puede incluir a pacientes con resistencia que se sospecha o se ha confirmado al tratamiento antifúngico de referencia (TR).
    E.2.2Secondary objectives of the trial
    - Evaluate the time to first negative blood culture
    - Evaluate the percentage of patients with Mycological Outcomes at End of Study Drug Treatment (EOST), End of Antifungal Treatment (EOT), and 2 and 4 weeks after EOT
    - Evaluate the percentage of patients with Treatment Success at EOT, and 2 and 4 weeks after EOT
    - Evaluate overall survival at Study Day 30
    - Evaluate safety parameters, including number of patients with treatment-emergent adverse events (TEAEs)
    - Evaluate pharmacokinetic (PK) parameters of APX001
    •Evaluar el tiempo transcurrido hasta el primer hemocultivo negativo
    •Evaluar el porcentaje de pacientes con acontecimientos micológicos al final del tratamiento con el fármaco del estudio (FTE), al final del tratamiento antifúngico (FT) y 2 y 4 semanas después del FT
    •Evaluar el porcentaje de pacientes con éxito del tratamiento al FT y a las 2 y 4 semanas del FT
    •Evaluar la supervivencia global el día 30 del estudio
    •Evaluar parámetros de seguridad, incluido el número de pacientes con acontecimientos adversos aparecidos durante el tratamiento (AAT)
    •Evaluar parámetros farmacocinéticos (FC) de APX001
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female 18 to 80 years of age (inclusive)
    2. New diagnosis of candidemia based on a blood sample drawn within 96 hours of dosing with:
    a. Positive blood culture for Candida spp., including those Candida spp. with suspected (in the opinion of the Investigator) or documented resistance to at least 1 SOC systemic antifungal agent
    or
    b. Positive result from a Sponsor-approved rapid diagnostic blood test for Candida spp. infection (a rapid diagnostic test may be used to begin eligibility assessments; however, a subsequent confirmatory blood culture is required prior to dosing of APX001)
    3. Able to have pre-existing intravascular catheters removed and replaced (if necessary)
    4. Females of childbearing potential must have a negative urine pregnancy test
    1.Varones o mujeres, de 18 a 80 años de edad (ambos inclusive)
    2.Nuevo diagnóstico de candidemia basado en una muestra de sangre extraída en las 96 horas previas a la administración con: a) Hemocultivo positivo para hongos del género Candida, incluidos aquellos con presunta resistencia (en opinión del investigador) o resistencia confirmada a, como mínimo, 1 fármaco antifúngico sistémico de referencia. o b) Resultado positivo según una prueba en sangre aprobada por el promotor para el diagnóstico rápido de infección por hongos del género Candida (una prueba de diagnóstico rápido puede utilizarse para comenzar las evaluaciones de la elegibilidad, pero deberá realizarse un hemocultivo de confirmación posteriormente antes de administrar APX001).
    3.Pacientes a los que se puedan retirar y sustituir (en caso necesario) catéteres intravasculares preexistentes
    4.La mujeres capaces de concebir deben dar un resultado negativo en una prueba de embarazo en orina
    E.4Principal exclusion criteria
    1. Neutropenia defined as absolute neutrophil count <500 cells/µL
    2. Diagnosis of deep-seated Candida-related infections causing intraperitoneal Candidiasis, septic arthritis, osteomyelitis, endocarditis, myocarditis, meningitis, or central nervous system infection or site of infection that would require antifungal treatment to exceed maximal duration of study drug (14 days)
    3. Hepatosplenic Candidiasis
    4. Blood culture, or any other culture, positive for C. krusei
    5. Received >2 days (>48 hours) equivalent of prior systemic antifungal treatment at approved doses to treat the current episode of candidemia (e.g., 2 consecutive doses of an echinocandin)
    Note: ≤ 5 days (≤120 hours) equivalent of prior antifungal treatment is permitted for patients with candidemia caused by Candida spp. with documented resistance to the specific prior antifungal administered.
    1.Neutropenia definida como un recuento absoluto de neutrófilos de  500 células/µl
    2.Diagnóstico de infecciones profundas relacionadas con hongos del género Candida que causan candidiasis intraperitoneal, artritis séptica, osteomielitis, endocarditis, miocarditis, meningitis o infección del sistema nervioso central o foco infeccioso que requeriría tratamiento antifúngico durante un periodo superior a la duración máxima del tratamiento con el fármaco del estudio (14 días)
    3.Candidiasis hepatoesplénica
    4.Hemocultivo, o cualquier otro tipo de cultivo, positivo para C. krusei
    5.Haber recibido el equivalente a  2 días (> 48 horas) de un tratamiento antifúngico sistémico previo en dosis aprobadas para tratar el episodio actual de candidemia (p. ej., 2 dosis consecutivas de una equinocandina)
    Nota: Se permite el equivalente a ≤ 5 días (≤ 120 horas) de un tratamiento antifúngico previo en los pacientes con candidemia causada por hongos del género Candida con resistencia documentada al antifúngico específico administrado anteriormente.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is Treatment Success at EOST as determined by the Data Review Committee (DRC).
    El parámetro principal de la eficacia es el éxito del tratamiento al FTE según determine el Comité de Revisión de Datos (Data Review Commitee, DRC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of the trial
    Fin del ensayo clínico
    E.5.2Secondary end point(s)
    - Time to first negative blood culture
    - Percentage of patients with Mycological Outcomes at EOST, EOT, and 2 and 4 weeks after EOT
    - Percentage of patients with Treatment Success at EOT, and 2 and 4 weeks after EOT
    - Overall survival at Study Day 30
    - Number of patients with TEAEs
    •Tiempo transcurrido hasta el primer hemocultivo negativo
    •Porcentaje de pacientes con acontecimientos micológicos al FTE, al FT y 2 y 4 semanas después del FT
    •Porcentaje de pacientes con éxito del tratamiento al FT, y a las 2 y 4 semanas del FT
    •Supervivencia global el día 30 del estudio
    •Número de pacientes con AAT
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At End of Study Drug Treatment (EOST)
    - At End of Antifungal Treatment (EOT)
    - At Follow-up (2 Weeks and 4 Weeks After End of Antifungal Treatment)
    - Al final del tratamiento con medicación del estudio (EOST)
    - Al final del tratamiento antifúngico (EOT)
    - Al seguimiento (2 y 4 semanas después del fin del tratamiento antifúngico)
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Belgium
    Germany
    Israel
    Spain
    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
    LVLS
    Ultima visita del último paciente
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Transient loss of consciousness- mechanically ventilated, sedation, septic shock ICU patients
    Pacientes con pérdida transitoria de conciencia - ventilación mecánica, sedación, choque séptico, pacientes de UCI
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 20
    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 Decision2018-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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