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    Summary
    EudraCT Number:2019-002991-15
    Sponsor's Protocol Code Number:SOLTI-1804
    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:2019-09-04
    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 number2019-002991-15
    A.3Full title of the trial
    HER2-PREDICT: Estudio Traslacional De Muestras De Tumor Procedentes De Los Ensayos Ds8201-A-U301 y Ds8201-A-U302
    HER2-PREDICT: Estudio Traslacional De Muestras De Tumor Procedentes De Los Ensayos Ds8201-A-U301 y Ds8201-A-U302
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Biological Effect in Tumor Samples from Clinical Trial Patients Treated with Ds8201
    Estudio sobre el efecto biologíco en muestras de tumor de pacientes de ensayo clínico que reciben tratamiento con Ds8201
    A.4.1Sponsor's protocol code numberSOLTI-1804
    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 SponsorSOLTI
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDaiichi Sankyo Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportDaiichi Sankyo Company, Limited
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSOLTI
    B.5.2Functional name of contact pointArea Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressBalmes, 89 3º 7º
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number+34933436302
    B.5.5Fax number+34932702383
    B.5.6E-mailregsolti@gruposolti.org
    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.3.2Product code DS-8201a
    D.3.4Pharmaceutical form Powder 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 INNtrastuzumab deruxtecan
    D.3.9.2Current sponsor codeDS-8201A
    D.3.9.3Other descriptive nameAnti-HER2 antibody-drug conjugate
    D.3.9.4EV Substance CodeSUB188940
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Her2‑positive, unresectable and/or metastatic breast cancer.
    Cáncer de mama HER2+ inoperable y/o metastásico
    E.1.1.1Medical condition in easily understood language
    Her2‑positive, unresectable and/or metastatic breast cancer.
    Cáncer de mama HER2+ inoperable y/o metastásico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To identify the optimal ERBB2 mRNA cut-point predictive of DS-8201 response
    -Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts.
    -Identificar el valor de corte óptimo del ARNm del ERBB2 que prediga la respuesta a DS-8201
    -Correlación de las concentraciones de ARNm de ERBB2 (como variable continua) en muestras tumorales FFIP basales con la respuesta global en las cohortes tratadas con DS8201a.
    E.2.2Secondary objectives of the trial
    -To evaluate the association of mRNA ERBB2 levels with progression-free survival and overall survival.
    -To evaluate the association of the PAM50 intrinsic subtypes (Luminal A, Luminal B, HER2-enriched and Basal-like) with overall response rate, progression free survival (PFS) and overall survival (OS).
    -To evaluate the association of immune-related genes with overall response, progression free survival (PFS) and overall survival (OS).
    -To design a new gene expression signature predictive of DS8201a benefit.
    -To evaluate the benefit of DS8201a across somatic mutations.
    -To correlate early changes in ctDNA with DS8201a benefit.
    -To identify acquired somatic mutations of resistance to DS8201a upon progression in plasma samples
    -Evaluar la asociación de las concentraciones de ARNm de ERBB2 con la supervivencia sin progresión y la supervivencia global.
    -Evaluar la asociación de los subtipos intrínsecos PAM50 (luminal A, luminal B, enriquecido con HER2 y seudobasal) con la tasa de respuesta global, la supervivencia sin progresión (SSP) y la supervivencia global (SG).
    -Evaluar la asociación de genes relacionados con la inmunidad con la respuesta global, la supervivencia sin progresión (SSP) y la supervivencia global (SG).
    -Diseñar una nueva firma de expresión génica predictiva del efecto beneficioso de DS8201a.
    -Evaluar el efecto beneficioso de DS8201a en todas las mutaciones somáticas.
    -Correlacionar los cambios precoces del ADNtc con el efecto beneficioso de DS8201a.
    -Identificar mutaciones somáticas adquiridas de resistencia a DS8201a tras la progresión en muestras de plasma
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Women ≥18 years old who previously participated in Daichi Sankyo INC. sponsored Ds8201-A-U301 and Ds8201-A-U302, consented for the obtention of a fresh biopsy or for the donation of an archival metastatic biopsy and the future use of their tumor samples in breast cancer research may be enrolled.
    2.The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
    3.Fulfill all inclusion and exclusion criteria of the Ds8201-A-U301 or U302 trials prior to inclusion.
    4.The patient who have received at least one dose of the study treatments in Ds8201-A-U301 or U302 trials.
    5.Availability of FFPE tumor block, collected prior to the inclusion in Ds8201-A-U301 or U302 trial, with an associated pathology report. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for PAM50 analysis prior to enrollment. Patients whose tumor tissue is not evaluable for central testing are not eligible.
    -Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions or biopsies from bone metastases.
    -Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.
    6.Must be able to provide blood sample(s).
    1.Puede reclutarse a las mujeres ≥ 18 años que participaron previamente en los estudios D8201-A-U301 y D8201-A-U302 promovidos por Daichi Sankyo INC. que hayan dado su consentimiento para la obtención de una nueva biopsia o para la donación de una biopsia metastásica de archivo y el uso futuro de sus muestras tumorales en la investigación del cáncer de mama.
    2.La participante (o su representante legal si procede) da su consentimiento informado por escrito para el estudio.
    3.Cumplir todos los criterios de inclusión y exclusión de los ensayos Ds8201-A-U301 o U302 antes de la inclusión.
    4.La paciente ha recibido al menos una dosis de los tratamientos del estudio en los ensayos Ds8201-A-U301 o U302.
    5.Disponibilidad de un bloque tumoral FFIP, obtenido antes de la inclusión en los ensayos D8201-A-U301 o U302, con un informe anatomopatológico asociado. El tejido tumoral debe ser de buena calidad basándose en el contenido tumoral total y viable, y deberá evaluarse de forma centralizada para el análisis PAM50 antes del reclutamiento. No son elegibles las pacientes cuyo tejido tumoral no sea evaluable para el análisis central.
    -Son muestras aceptables las biopsias con aguja gruesa de tejido tumoral profundo o biopsias por escisión, incisión, con sacabocados o con pinzas de lesiones cutáneas, subcutáneas o mucosas o las biopsias de metástasis óseas.
    -No son aceptables las muestras de aspiración con aguja fina, cepillado, sedimento celular de derrame pleural y de lavado.
    6.Deberán poder proporcionar muestras de sangre.
    E.4Principal exclusion criteria
    Not having participated to the Daichi Sankyo INC. sponsored Ds8201-A-U301, Ds8201-A-U302 trials.
    No haber participado en los ensayos D8201-A-U301, D8201-A-U302 promovidos por Daichi Sankyo INC.
    E.5 End points
    E.5.1Primary end point(s)
    -To identify the optimal ERBB2 mRNA cut-point predictive of DS-8201 response
    -Correlation of mRNA ERBB2 levels (as a continuous variable) in baseline FFPE tumor samples with overall response in the DS8201a-treated cohorts.
    -Identificar el valor de corte óptimo del ARNm del ERBB2 que prediga la respuesta a DS-8201
    -Correlación de las concentraciones de ARNm de ERBB2 (como variable continua) en muestras tumorales FFIP basales con la respuesta global en las cohortes tratadas con DS8201a.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the study
    Al finalizar el estudio
    E.5.2Secondary end point(s)
    -To evaluate the association of mRNA ERBB2 levels with progression-free survival and overall survival.
    -To evaluate the association of the PAM50 intrinsic subtypes (Luminal A, Luminal B, HER2-enriched and Basal-like) with overall response rate, progression free survival (PFS) and overall survival (OS).
    -To evaluate the association of immune-related genes with overall response, progression free survival (PFS) and overall survival (OS).
    -To design a new gene expression signature predictive of DS8201a benefit.
    -To evaluate the benefit of DS8201a across somatic mutations.
    -To correlate early changes in ctDNA with DS8201a benefit.
    -To identify acquired somatic mutations of resistance to DS8201a upon progression in plasma samples
    -Evaluar la asociación de las concentraciones de ARNm de ERBB2 con la supervivencia sin progresión y la supervivencia global.
    -Evaluar la asociación de los subtipos intrínsecos PAM50 (luminal A, luminal B, enriquecido con HER2 y seudobasal) con la tasa de respuesta global, la supervivencia sin progresión (SSP) y la supervivencia global (SG).
    -Evaluar la asociación de genes relacionados con la inmunidad con la respuesta global, la supervivencia sin progresión (SSP) y la supervivencia global (SG).
    -Diseñar una nueva firma de expresión génica predictiva del efecto beneficioso de DS8201a.
    -Evaluar el efecto beneficioso de DS8201a en todas las mutaciones somáticas.
    -Correlacionar los cambios precoces del ADNtc con el efecto beneficioso de DS8201a.
    -Identificar mutaciones somáticas adquiridas de resistencia a DS8201a tras la progresión en muestras de plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study.
    Al finalizar el 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 No
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Identification of molecular biomarkers associated with drug response DS8201
    Identificación de biomarcadores moleculares asociados a la respuesta al fármaco DS8201
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last visit last subject
    Ultima visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months51
    E.8.9.1In the Member State concerned days
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state180
    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 Decision2019-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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