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    Summary
    EudraCT Number:2018-003942-18
    Sponsor's Protocol Code Number:ASTX727-06
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-27
    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 number2018-003942-18
    A.3Full title of the trial
    An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)
    Estudio de extensión abierto y multicéntrico para pacientes que participaron en estudios clínicos previos de ASTX727 (dosis estándar)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727
    Estudio de extensión para pacientes que participaron en estudios clínicos previos de ASTX727
    A.4.1Sponsor's protocol code numberASTX727-06
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04093570
    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 SponsorAstex 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 supportAstex Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstex Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address4420 Rosewood Drive, Suite 200
    B.5.3.2Town/ cityPleasanton, CA
    B.5.3.3Post code94588
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1925560 2855
    B.5.6E-mailarturo.galano@astx.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 nameASTX727 (cedazuridine and decitabine)
    D.3.2Product code ASTX727
    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 INNDECITABINE
    D.3.9.1CAS number 2353-33-5
    D.3.9.2Current sponsor codeDAC, DCT-0416, 182, 31022
    D.3.9.4EV Substance CodeSUB06932MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number35
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCEDAZURIDINE
    D.3.9.1CAS number 1141397-80-9
    D.3.9.2Current sponsor codeE7727
    D.3.9.4EV Substance CodeSUB194550
    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
    Acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors
    Leucemia mieloide aguda (LMA), síndromes mielodisplásicos (SMD), o tumores sólidos
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cáncer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10000880
    E.1.2Term Acute myeloid leukaemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10065252
    E.1.2Term Solid tumor
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To provide ongoing long-term treatment with ASTX727 for subjects who were benefitting from ASTX727 treatment in a previous Astex-sponsored clinical study.
    Proporcionar tratamiento a largo plazo con ASTX727 a los pacientes que estuvieran obteniendo un beneficio del tratamiento con ASTX727 en un estudio clínico previo promovido por Astex
    E.2.2Secondary objectives of the trial
    To obtain information on survival and disease status, including conversion to AML (subjects with hematological malignancy only).
    Obtener información sobre la supervivencia y el estado de la enfermedad, incluida la conversión a LMA (solo pacientes con neoplasia maligna hematológica)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Previous participation in an Astex-sponsored ASTX727 clinical trial (including but not limited to studies ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex.
    2) Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion. (Subjects must not be withdrawn from the parent study until eligibility for this study is confirmed.)
    3) Subject is able to understand and comply with the study procedures and understands the risks involved in the study.
    4) Subject provides legally effective informed consent before undergoing any study-specific procedure.
    5) Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment.
    6) Men with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure (user dependent or with low user dependency) while receiving treatment with ASTX727 for at least 3 months after completing treatment and must agree not to father a child while receiving study treatment for at least 3 months after completing ASTX727 treatment.
    1) Participación previa en un estudio clínico de ASTX727 promovido por Astex (incluidos, entre otros, los estudios ASTX727-01, ASTX727-02, ASTX727-04, ASTX727-17, ASTX727-18) donde el paciente recibía ASTX727 y seguía recibiéndolo en el momento de finalización del estudio, de acuerdo con la determinación de Astex.
    2) En opinión del investigador responsable del tratamiento, el paciente seguía beneficiándose del tratamiento con ASTX727 en el momento de la finalización del estudio principal. (No se debe retirar a los pacientes del estudio principal hasta que se haya confirmado la elegibilidad para participar en este estudio).
    3) El paciente es capaz de entender y cumplir los procedimientos del estudio y comprende los riesgos que este implica.
    4) El paciente otorga el consentimiento informado con validez legal antes de realizar cualquier procedimiento específico del estudio.
    5) Las mujeres con capacidad de concebir (de acuerdo con las recomendaciones del Clinical Trial Facilitation Group [CTFG])no deben estar embarazadas ni en periodo de lactancia y deben tener un resultado negativo en la prueba de embarazo en la selección. Las mujeres con capacidad de concebir deben comprometerse a utilizar 1 método anticonceptivo muy eficaz con baja dependencia del usuario y aceptar no quedarse embarazadas en los 6 meses posteriores a la finalización del tratamiento.
    6) Los varones cuya pareja sea una mujer con capacidad de concebir deben comprometerse a utilizar preservativo masculino y aconsejar a su pareja que utilice 1 método anticonceptivo muy eficaz (dependiente del usuario o con baja dependencia del usuario), así como aceptar no concebir un hijo mientras estén recibiendo tratamiento con ASTX727 ni, como mínimo, en los 3 meses posteriores a la finalización del tratamiento.
    E.4Principal exclusion criteria
    1) Any subject who, in the opinion of the investigator, may have other conditions or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
    1) Cualquier paciente que, en opinión del investigador, pueda tener otra enfermedad o cuyos datos de seguridad obtenidos durante el estudio principal indiquen que los riesgos de continuar el tratamiento con ASTX727 podrían superar los beneficios.
    E.5 End points
    E.5.1Primary end point(s)
    Safety as measured by AEs
    Seguridad determinada por los AA
    E.5.1.1Timepoint(s) of evaluation of this end point
    AE monitoring - Day 1 of each cycle and at Safety Follow-up
    Monitorización de los AA - Día 1 de cada ciclo y seguimiento de seguridad
    E.5.2Secondary end point(s)
    Survival and disease status, including conversion to AML (subjects with hematological malignancy only).
    Supervivencia y estado de la enfermedad, incluida la conversión a LMA (solo pacientes con neoplasia maligna hematológica)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Survival and disease status assessment - quaterly until death or until subject withdrawal from the study
    Evaluación de la supervivencia y estado de la enfermedad - trimestralmente hasta la muerte o hasta que el paciente sea retirado del estudio.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    Russian Federation
    United States
    European Union
    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
    LSLV
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days20
    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.1.1.1In 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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 23
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 300
    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 Decision2021-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusOngoing
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