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    Summary
    EudraCT Number:2016-002349-50
    Sponsor's Protocol Code Number:M16TGA
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-002349-50
    A.3Full title of the trial
    Phase I/II study with galunisertib (LY2157299) combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer and an
    activated TGF-β signature
    Studio di fase I/II con galunisertib in combinazione con capecitabina in pazienti affetti da tumore del colon-retto avanzato refrattarioallachemioterapia e con una signature genetica TGF-β like.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase I/II study with galunisertib combined with chemotherapy in patients with metastasized, resistent bowle cancer and an activated TGF-beta signature.
    Studio di fase I/II con galunisertib in combinazione con capecitabina in pazienti affetti da tumore del colon-retto avanzato refrattarioallachemioterapia e con una signature genetica TGF-β like.
    A.3.2Name or abbreviated title of the trial where available
    Phase I/II study with galunisertib combined with chemotherapy in patients with metastasized, resiste
    M16TGA: galunisertib e capecitabina nel mCRC con signature genetica TGF-beta like
    A.4.1Sponsor's protocol code numberM16TGA
    A.5.4Other Identifiers
    Name:EORTC 1615Number:MOTRICOLOR CT1
    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 SponsorTHE NETHERLANDS CANCER INSTITUTE
    B.1.3.4CountryNetherlands
    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 supportEli Lilly
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNKI-AVL
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportThe Directorate-General for Research and Innovatio
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNetherlands Cancer Institute
    B.5.2Functional name of contact pointJan Schellens
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205122961
    B.5.5Fax number0031205122572
    B.5.6E-mailj.schellens@nki.nl
    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 namegalunisertib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 700874-74-2
    D.3.9.2Current sponsor codeLY2157299
    D.3.9.3Other descriptive nameGALUNISERTIB
    D.3.9.4EV Substance CodeSUB126321
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    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 Yes
    D.2.1.1.1Trade name CAPECITABINE
    D.2.1.1.2Name of the Marketing Authorisation holder/
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCAPECITABINE
    D.3.2Product code SUB12474MIG
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPECITABINA
    D.3.9.2Current sponsor codeSUB12474MIG
    D.3.9.3Other descriptive nameCAPECITABINA
    D.3.9.4EV Substance CodeSUB12474MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150 to 500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    colorectal carcinoma
    colorectal carcinoma
    E.1.1.1Medical condition in easily understood language
    intestinal cancer
    intestinal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal 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
    Phase I: To determine the recommended phase 2 dose (RP2D) of galunisertib plus capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

    Phase II: To determine the anti-tumor activity, as measured by response rate (RR) of galunisertib in combination with capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.
    Fase I: determinare la dose raccomandata per la fase 2 (RP2D) di galunisertib in combinazione con capecitabina in pazienti affetti da CRC resistente a chemioterapia con una signature genetica TGF-β like

    Fase II: determinare l’attività antitumorale, misurata in base al tasso di risposta (RR) di galunisertib in combinazione con capecitabina in pazienti affetti da CRC resistente a chemioterapia con una signature genetica TGF-β like.
    E.2.2Secondary objectives of the trial
    - To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events
    - To assess anti-tumor activity of galunisertib in combination with chemotherapy, as measured by duration of response, time to response and, progression free survival (phase II only) and overall survival (phase II only)
    - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
    - To explore genetic determinants of response to galunisertib in combination with chemotherapy, as measured by baseline molecular status of potential predictive markers of tumor response
    - To explore the potential mechanism of resistance to galunisertib in combination with chemotherapy, as measured by gene alterations/expression profiles (e.g. baseline, relapse) in tumor tissue upon progression
    - Caratterizzare la sicurezza e la tollerabilità di galunisertib in combinazione con regimi di chemioterapia, valutate in base ad incidenza e gravità degli eventi avversi
    - Valutare l’attività antitumorale di galunisertib in combinazione con chemioterapia, misurata in base a durata della risposta, tempo alla risposta, sopravvivenza libera da progressione (solo fase II) e sopravvivenza globale (solo fase II)
    - Determinare il profilo farmacocinetico di galunisertib in combinazione con chemioterapia, valutato in base alle concentrazioni plasmatiche
    - Analizzare i determinanti genetici della risposta a galunisertib in combinazione con chemioterapia, valutati in base allo stato molecolare basale di potenziali marcatori predittivi di risposta del tumore
    - Esplorare il potenziale meccanismo di resistenza a galunisertib in combinazione con chemioterapia, valutato in base ai profili di alterazione/espressione genica (ad es., al basale, alla recidiva) nel tessuto tumorale al momento della progr
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological or cytological proof of CRC;
    2. Disease progression or relapse upon first line of treatment (maximum lines of treatment is one for phase I and phase II of this study) for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);
    3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia;
    4. Age ≥ 18 years;
    5. Able and willing to give written informed consent;
    6. WHO performance status of ≤ 1;
    7. LVEF ≥ 55%;
    8. Able and willing to undergo blood sampling for PK and PD analysis;
    9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment
    10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity;
    11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part);
    12. Minimal acceptable safety laboratory values
    a. ANC of ≥ 1.5 x 109 /L
    b. Platelet count of ≥ 100 x 109 /L
    c. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases
    d. Renal function as defined by serum creatinine ≤1.5 x ULN
    e. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);
    13. Negative pregnancy test (urine or serum) for female patients with childbearing potential.
    1. Conferma istologica o citologica di CRC
    2. Progressione di malattia o recidiva dopo una prima linea di trattamento per CRC avanzato con chemioterapia contenente una fluoropirimidina come agente singolo o in combinazione (sono ammesse combinazioni con oxaliplatino, irinotecan, bevacizumab e cetuximab/panitumumab)
    3. Documentazione scritta di signature genetica TGF-βlike, determinata mediante test validato di Agendia
    4. Età 18 anni
    5. Soggetto in grado di, e disponibile, a fornire consenso informato scritto, con firma del modulo di consenso informato prima dell’inizio della sperimentazione
    6. Stato di validità OMS ≤1
    7. FEVS ≥55%
    8. Soggetto in grado di, e disponibile a sottoporsi a prelievi di sangue per l’analisi farmacocinetica (PK) e farmacodinamica (PD)
    9. Soggetto in grado di, e disponibile a sottoporsi a biopsia tumorale prima dell’avvio, durante e alla fine del trattamento
    10. Aspettativa di vita 3 mesi, che consenta un follow-up adeguato della valutazione della tossicità e dell’attività antitumorale
    11. Malattia valutabile secondo i Criteri di valutazione della risposta nei tumori solidi (RECIST) 1.1 (malattia misurabile per la parte di fase II; per la parte di fase I è sufficiente che la malattia sia valutabile)
    12. Valori minimi accettabili degli esami di laboratorio per la sicurezza
    a. Conta assoluta dei neutrofili (ANC) 1,5 x 109/l
    b. Conta piastrinica 100 x 109 /L
    c. Funzione epatica definita da livelli sierici di bilirubina 1,5 x il limite superiore della norma (ULN), ALAT e ASAT 3,0 x ULN o ALAT e ASAT <5 x ULN nei pazienti con metastasi epatiche
    d. Funzione renale definita da livelli sierici di creatinina 1,5 x ULN
    e. Clearance della creatinina 50 ml/min (secondo la formula di Cockroft-Gault o la formula “Modifica della dieta nella patologia renale” [MDRD])
    13. Test di gravidanza (urinario o sierico) negativo per le pazienti in età fertile
    E.4Principal exclusion criteria
    1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment;
    2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A>T genotype);
    3. Symptomatic or untreated leptomeningeal disease;
    4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids;
    5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart.
    6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral galunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection);
    7. Woman who are pregnant or breast feeding;
    8. Unreliable contraceptive methods. Both men and women enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: condom, sterilization, other barrier contraceptive measures preferably in combination with condoms);
    9. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed;
    10. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery;
    11. Active infection requiring systemic antibiotics or uncontrolled infectious disease;
    12. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients;
    13. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study;
    14. Known hypersensitivity to one of the study drugs or excipients.
    1. Qualsiasi trattamento con farmaci sperimentali nei 30 giorni precedenti la somministrazione della prima dose di trattamento sperimentale
    2. Deficit noto o sospetto di diidropirimidina deidrogenasi (genotipo mutato per DPD*2A, genotipo 1236 GA, genotipo 1679TG e genotipo 2846A>T)
    3. Malattia leptomeningea sintomatica o non trattata
    4. Metastasi cerebrali sintomatiche. È consentito l’arruolamento di pazienti, trattati o meno in precedenza per queste condizioni, che appaiano asintomatici in assenza di terapia corticosteroidea. Le metastasi cerebrali devono essere stabili, con verifica mediante esami di imaging (ad es., RM o TC cerebrale eseguita allo screening che non dimostri alcuna attuale evidenza di metastasi cerebrali in progressione). I pazienti non possono ricevere farmaci antiepilettici induttori enzimatici o corticosteroidi
    5. Anamnesi di patologia cardiaca, tra cui infarto miocardico nei 6 mesi precedenti l’ingresso nello studio, angina pectoris instabile, insufficienza cardiaca congestizia di classe III/IV secondo la classificazione della New York Heart Association (Associazione dei cardiologi di New York) o ipertensione non controllata, anomalie cardiache maggiori, predisposizione allo sviluppo di aneurismi, inclusa anamnesi familiare di aneurismi, sindrome di Marfan, valvola aortica bicuspide o evidenza di lesione a carico dei grossi vasi del cuore
    6. Compromissione della funzione gastrointestinale (GI) o patologia GI che possa alterare in modo significativo l’assorbimento di galunisertib per via orale (ad es., patologie ulcerative, nausea non controllata, vomito, diarrea, sindrome da malassorbimento, resezione dell’intestino tenue)
    7. Donne in gravidanza o che allattano al seno
    8. Metodi contraccettivi non affidabili. Sia gli uomini che le donne arruolati in questa sperimentazione devono acconsentire ad utilizzare un metodo contraccettivo affidabile per tutta la durata dello studio (sono metodi contraccettivi adeguati il preservativo, la sterilizzazione, altre misure contraccettive di barriera preferibilmente in combinazione con preservativi)
    9. Radioterapia o chemioterapia nelle ultime 2 settimane (30 giorni per i farmaci sperimentali) prima della somministrazione della prima dose di trattamento sperimentale. È consentita la radioterapia palliativa (1 x 8 Gy)
    10. Pazienti sottoposti a qualsiasi intervento chirurgico maggiore nelle ultime 2 settimane prima dell’avvio del farmaco dello studio o che non si siano ripresi completamente da un precedente intervento chirurgico
    11. Infezione in fase attiva con necessità di terapia antibiotica per via sistemica o patologia infettiva non controllata
    12. Pazienti con anamnesi nota di epatite B o C o con infezione nota da virus dell’immunodeficienza umana di tipo 1 (HIV-1) o 2 (HIV-2)
    13. Altra condizione medica o psichiatrica o anomalia di laboratorio grave, acuta o cronica, che possa aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco dello studio o che possa interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renderebbe il paziente un candidato non idoneo per lo studio
    14. Ipersensibilità nota a uno dei farmaci dello studio o degli eccipienti
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: To determine the recommended phase 2 dose (RP2D) of galunisertib plus capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.

    Phase II: To determine the anti-tumor activity, as measured by response rate (RR) of galunisertib in combination with capecitabine in patients with chemotherapy resistant activated TGF-β signature-like CRC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    E.5.2Secondary end point(s)
    - To characterize the safety and tolerability of galunisertib in combination with chemotherapy regimens, as assessed by the incidence and severity of adverse events
    - To assess anti-tumor activity of galunisertib in combination with chemotherapy, as measured by duration of response, time to response and, progression free survival (phase II only) and overall survival (phase II only)
    - To determine the pharmacokinetic profile of galunisertib in combination with chemotherapy, as measured by plasma concentrations
    - To explore genetic determinants of response to galunisertib in combination with chemotherapy, as measured by baseline molecular status of potential predictive markers of tumor response
    - To explore the potential mechanism of resistance to galunisertib in combination with chemotherapy, as measured by gene alterations/expression profiles (e.g. baseline, relapse) in tumor tissue upon progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharmacokinetic study
    pharmacokinetic study
    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 trial0
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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 Information not present in EudraCT
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months17
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    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 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 Yes
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 31
    F.4.2.2In the whole clinical trial 31
    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
    none
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation MoTriColor Consortium
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-08-05
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