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    Summary
    EudraCT Number:2015-001718-80
    Sponsor's Protocol Code Number:PRM-151G-101
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-10-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-001718-80
    A.3Full title of the trial
    A Phase 2, Prospective Study Of PRM-151 In Subjects With Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), Or Post-Essential Thrombocythemia MF (post-ET MF)
    Studio prospettico, di fase 2, di PRM-151 in soggetti affetti da mielofibrosi primaria (MFP), mielofibrosi post-policitemia vera (MF post-PV) o mielofibrosi post-trombocitemia essenziale (MF post-TE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test intravenous PRM-151 to see how different doses of PRM-151 act in the body and blood of people with myelofibrosis - a disorder of the bone marrow, in which the marrow is replaced by fibrotic tissue.
    Uno studio per testare l'uso intravenoso di PRM-151 e vedere come due differenti dosi di PRM-151 agiscono nel corpo e nel sangue di soggetti affetti da mielofibrosi - una malattia del midollo osseo, nel quale il midollo è sostituito da tessuto fibroso.
    A.3.2Name or abbreviated title of the trial where available
    PRM-151G-101
    PRM-151G-101
    A.4.1Sponsor's protocol code numberPRM-151G-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01981850
    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 SponsorPROMEDIOR, 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 supportPromedior Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGB Pharma Services & Consulting S.r.l.
    B.5.2Functional name of contact pointUnità Ricerca Clinica
    B.5.3 Address:
    B.5.3.1Street AddressVia Ferreri, 11
    B.5.3.2Town/ cityPavia
    B.5.3.3Post code27100
    B.5.3.4CountryItaly
    B.5.4Telephone number00390382530676
    B.5.5Fax number00390382302619
    B.5.6E-mailinfo@gbpharmaservices.it
    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 numberEU/3/14/1366; EU/3/14/1365; EU/3/14/1358
    D.3 Description of the IMP
    D.3.1Product namePRM-151
    D.3.2Product code [PRM-151]
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1387453-03-3
    D.3.9.2Current sponsor codePRM-151
    D.3.9.3Other descriptive nameRecombinant human Pentraxin-2, rhPTX-2 - Recombinant human Serum Amyloid P, rhSAP
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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 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 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
    Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), Or Post-Essential Thrombocythemia MF (post-ET MF)
    Mielofibrosi primaria (MFP), mielofibrosi post-policitemia vera (MF post-PV) o mielofibrosi post-trombocitemia essenziale (MF post-TE).
    E.1.1.1Medical condition in easily understood language
    Myelofibrosis - a disorder of the bone marrow, in which the marrow is replaced by scar (fibrous) tissue.
    Mielofibrosi - una malattia del midollo osseo, nel quale il midollo è sostituito da tessuto fibrotico.
    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 PT
    E.1.2Classification code 10028537
    E.1.2Term Myelofibrosis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074689
    E.1.2Term Post polycythemia vera myelofibrosis
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10074690
    E.1.2Term Post essential thrombocythemia myelofibrosis
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by = 1 grade in intermediate-1, intermediate-2, and high risk subjects with PMF, post-PV MF, or post ETMF
    who are anemic or thrombocytopenic and who are ineligible for, intolerant of, or have had an inadequate response to ruxolitinib.
    Determinare l’effetto di tre differenti dosaggi di PRM-151 sulla riduzione di = 1 grado della fibrosi midollare nei soggetti a rischio intermedio-1, intermedio-2 o alto affetti da MFP, MF post-PV o MF post-TE, che sono anemici o trombocitopenici e che sono inidonei, intolleranti oppure hanno evidenziato una risposta inadeguata al trattamento con ruxolitinib.
    E.2.2Secondary objectives of the trial
    To determine if there is a difference in efficacy between the three doses of PRM-151 used in the study.
    To evaluate the safety and tolerability of three different doses of PRM-151.
    To assess the duration of effect of three doses of PRM-151 on reduction in bone marrow fibrosis.
    To assess the effect and duration of effect of three
    doses of PRM-151 on disease related anemia, thrombocytopenia, and constitutional symptoms.
    To assess IWG-MRT response (Complete Response, Partial Response, Clinical Improvement), stable and progressive disease in subjects treated with three doses of PRM-151.
    Determinare se vi sia una differenza in termini di efficacia tra i tre dosaggi di PRM-151 utilizzati nello studio.
    Valutare la sicurezza e la tollerabilità dei tre differenti dosaggi di PRM-151.
    Verificare la durata dell’effetto dei tre dosaggi di PRM-151 ai fini della riduzione della mielofibrosi
    Verificare la durata dell’effetto di tre dosaggi di PRM-151 su anemia, trombocitopenia e sintomi costituzionali correlati alla patologia.
    Verificare la risposta sulla base dei criteri stabiliti dall’IWG-MRT (International Working Group for Myelofibrosis Research and Treatment, Gruppo di Lavoro Internazionale per la Ricerca e il Trattamento delle Neoplasie Mieloproliferative) (risposta completa, risposta parziale, miglioramento clinico), malattia stabile e progressiva in soggetti trattati con i tre dosaggi di PRM-151.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects must be =18 years of age at the time of signing the Informed Consent Form (ICF);
    2. Subjects must voluntarily sign an ICF;
    3. Subjects must have a pathologically confirmed diagnosis of PMF as per the WHO diagnostic criteria or post ET/PV MF;
    4. At least Grade 2 marrow fibrosis according to the WHO Grading of Bone Marrow Fibrosis;
    5. Intermediate-1, intermediate -2, or high risk disease according to the IWG-MRT Dynamic International Prognostic Scoring System;
    6. A bone marrow biopsy must be performed within four weeks prior to Cycle 1 Day 1 treatment to establish the baseline fibrosis score;
    7. Subjects must not be candidates for ruxolitinib based on EITHER: a.Platelet count < 50 x 10^9/L, OR b. Hgb < 100 g/L, have received = 2 units PRBC in the 12 weeks prior to study entry, and be intolerant of or had inadequate response to ruxolitinib;
    8. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
    9. Life expectancy of at least twelve months;
    10. At least four weeks must have elapsed between the last dose of any MF-directed drug treatments for myelofibrosis (including investigational therapies) and study enrollment;
    11. Recovery to = Grade 1 or baseline of any toxicities due to prior systemic treatments, excluding alopecia;
    12. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if < 55 years or 12 months if > 55 years, must have a negative serum pregnancy test within four weeks prior to the first dose of study drug and must agree to use highly effective methods of birth control throughout the study.Highly effective methods of contraception include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation by oral, intravaginal, or transdermal administration; progestogen-only hormonal contraception associated with inhibition of ovulation by oral, injectable, or implantable administration; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; partner vasectomy, and total abstinence (only if total abstinence is the preferred method and usual lifestyle of thesubject). Adequate contraceptive use should be continued until 28 days after the final dose of the study drug.
    13. Ability to adhere to the study visit schedule and all protocol requirements;
    14. Must have adequate organ function as demonstrated by the following: • ALT (SGPT) and/or AST (SGOT) = 3x upper limit of normal (ULN), or = 4 x ULN (if upon judgment of the treating physician, it is
    believed to be due to extramedullary hematopoiesis [EMH] related to MF); • Direct bilirubin = 1.5 x ULN; or = 2x ULN (if upon judgment of the treating physician, it is believed to be due to EMH related to MF); • Serum creatinine = 2.5 x ULN.
    1.I soggetti devono avere =18 anni di età all’atto della firma del Modulo di Consenso Informato (CI);
    2.I soggetti devono firmare di propria volontà il CI;
    3.I soggetti devono avere una diagnosi di MFP confermata patologicamente in linea con i criteri diagnostici WHO (appendice C) o di MF post TE/PV;
    4.Almeno una mielofibrosi di grado 2 secondo il sistema di classificazione WHO (appendice D);
    5.Malattia a rischio intermedio-1, intermedio-2 o alto rischio secondo i criteri stabiliti dall’IWG-MRT (appendice E);
    6.Una biopsia del midollo osseo deve essere eseguita entro quattro settimane prima del trattamento in programma per il Giorno 1 del Ciclo 1 per stabilire il livello basale della fibrosi;
    7.I soggetti non devono essere idonei al trattamento con ruxolitinib per UNO DEI SEGUENTI FATTORI:
    a. Conta piastrinica < 50 x 109/l, OPPURE
    b. Hgb < 100 g/l, trasfusione di = 2 unità di PRBC (globuli rossi sanguigni) nelle 12 settimane precedenti l’arruolamento ed essere intolleranti o avere una risposta inadeguata a ruxolitinib;
    8.I soggetti devono avere un performance status ECOG (Eastern Cooperative Oncology Group) di 0-2. (Appendice F);
    9.Aspettativa di vita di almeno 12 mesi;
    10.Devono essere trascorse almeno quattro settimane tra l’ultima dose di qualunque trattamento farmacologico mirato per la mielofibrosi (anche sperimentale) e arruolamento nello studio;
    11.Miglioramento al grado= 1 o al livello del basale di eventuali tossicità causate da pregressi trattamenti sistemici, esclusa l’alopecia;
    12.Le donne in età fertile (DEF), vale a dire donne sessualmente mature non sterilizzate chirurgicamente né in stato di post-menopausa per almeno 24 mesi consecutivi se = 55 anni o 12 mesi se > 55 anni, devono avere un test di gravidanza eseguito sul siero negativo entro le quattro settimane precedenti la prima somministrazione di farmaco in studio e devono accettare di usare metodi anticoncezionali altamente efficaciper l’intera durata dello studio. Metodi di contraccezione altamente efficaci includono contraccezione ormonale combinata (contenente estrogeno e progesterone) associata ad inibizione dell'ovulazione per via orale, intravaginale, o somministrazione transdermica; contraccezione ormonale di solo progestinico associato a inibizione dell'ovulazione per via orale, iniettabile, impiantabile; dispositivo intrauterino (IUD); sistema intrauterino di ormone rilasciante (IUS); occlusione tubarica bilaterale; vasectomia, e l'astinenza totale (solo se l'astinenza totale è il metodo preferito e consueto dello stile di vita del soggetto). L'uso di contraccettivi adeguati deve essere continuato fino ad almeno 28 giorni dopo l'ultima dose del farmaco in studio;
    13.Capacità di rispettare il piano di visite dello studio e tutti i requisiti del protocollo;
    14.Avere una adeguata funzionalità degli organi, dimostrata dai seguenti parametri:
    • ALT (SGPT) e/o AST (SGOT) = 3x limite superiore della norma (ULN) o = 4 x ULN (se, a giudizio del medico curante, si ritiene causata da ematopoiesi extramidollare correlata alla MF);
    • bilirubina diretta = 1,5 x ULN; oppure = 2x ULN (se, a giudizio del medico curante, si ritiene causata da ematopoiesi extramidollare correlata alla MF);
    • creatinina sierica = 2,5x ULN.
    E.4Principal exclusion criteria
    1. White blood cell count > 25 x 10^9/L or > 10% peripheral blood blasts;
    2. Other invasive malignancies within the last 3 years, except nonmelanoma skin cancer and localized cured prostate and cervical cancer;
    3. History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months;
    4. Presence of active serious infection;
    5. Any serious, unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk ifhe/she were to participate in the study or confounds the ability to interpret data from the study;
    6. Known history of human immunodeficiency virus (HIV), or known active hepatitis A, B, or C infection;
    7. Organ transplant recipients other than bone marrow transplant;
    8. Women who are pregnant or lactating.
    1.Conta dei globuli bianchi > 25 x 109/l oppure > 10% dei blasti del sangue periferico ;
    2.Altre neoplasie invasive entro gli ultimi 3 anni, tranne carcinoma della pelle non melanoma e carcinoma prostatico o della cervice localizzato guarito;
    3.Pregresso ictus, angina instabile, infarto miocardico o aritmia ventricolare che richiedono terapia medica o controllo meccanico negli ultimi 6 mesi;
    4.Presenza di infezione seria in atto;
    5.Qualunque patologia medica o psichiatrica instabile seria che impedisca al soggetto (a giudizio dello sperimentatore) di firmare il consenso informato o qualunque condizione, inclusa la presenza di alterazioni dei parametri di laboratorio, che esporrebbe il soggetto a un rischio inaccettabile, se partecipasse allo studio, o sarebbe fuorviante per l’interpretazione dei dati ottenuti dallo studio;
    6.Storia nota di virus dell’immunodeficienza umana (HIV) o infezione nota in atto da virus dell’epatite A, B o C;
    7.Persone che hanno ricevuto trapianto d’organo diverso dal trapianto di midollo osseo;
    8.Donne in gravidanza o che allattano
    E.5 End points
    E.5.1Primary end point(s)
    Bone marrow response rate, defined as the percent of subjects with a reduction in bone marrow fibrosis score by at least one grade according to WHO criteria at any time during the study as determined by a central adjudication panel of expert hematopathologists, blinded to subject,treatment, and time of biopsy.
    • Tasso di risposta del midollo osseo definita come percentuale di soggetti che evidenziano una riduzione di almeno un grado del punteggio relativo alla mielofibrosi secondo i criteri WHO (appendice D) in qualunque momento dello studio, secondo quanto riscontrato da una commissione di esperti a livello centrale costituita da emato-patologi, che non sapranno soggetto, trattamento ricevuto, né la data della biopsia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At any time during the study.
    In qualsiasi momento dello studio.
    E.5.2Secondary end point(s)
    Comparison of primary and secondary efficacy parameters between doses.; Incidence of adverse events (AEs), serious adverse events (SAEs), and changes in laboratory test results.; Bone marrow improvement:
    - Bone marrow response rate at weeks 12, 24, and 36
    - Duration of bone marrow response.; Hemoglobin improvement; Platelet improvement; Hematologic improvement; Symptom improvement:
    -Percent of subjects with 25% and 50% reduction in MPN-SAF Total Symptom Score from baseline at Week 36
    -Mean change from baseline in EORTC QLQ-C30 at 36 weeks; Duration of all improvement parameters listed above; Percent of subjects with complete response, partial response, clinical improvement, stable disease, and progressive disease according to IWG-MRT criteria.
    Confronto dei parametri di efficacia primari e secondari tra le dosi.; Incidenza di eventi avversi (adverse events, AE), eventi avversi seri (serious adverse events, SAE) e variazioni dei parametri di laboratorio.; Miglioramento del midollo osseo:
    - Tasso di risposta del midollo osseo a 12, 24 e 36 settimane
    - Durata della risposta del midollo osseo
    ; Miglioramento dell’emoglobina ; Miglioramento delle piastrine; Miglioramento ematologico; Miglioramento sintomatologico:
    - Percentuale di soggetti con riduzione del 25% e 50% del punteggio totale alla scala MPN-SAF a 36 settimane rispetto al punteggio basale
    - Variazione media del punteggio alla scala EORTC QLQ-C30 a 36 settimane rispetto al punteggio basale.; Durata di tutti i parametri di miglioramento indicati sopra; • Percentuale di soggetti con risposta completa, risposta parziale, miglioramento clinico, malattia stabile e malattia progressiva secondo i criteri stabiliti dall’IWG-MRT.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of Cycle 9.; At the end of Cycle 9.; At the end of cycle 9.; At the end of Cycle 9; At the end of Cycle 9.; At the end of Cycle 9.; At the end of Cycle 9.; At the end of Cycle 9.; At the end of Cycle 9.
    Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.; Alla fine del ciclo 9.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial3
    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 EEA4
    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 Information not present in EudraCT
    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
    Israel
    United States
    France
    Germany
    Italy
    Netherlands
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 51
    F.4.2.2In the whole clinical trial 98
    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)
    All subjects completing 9 cycles of the originally assigned treatment may switch to an open label extension and receive PRM-151 10mg/kg every 4 weeks.
    The first cycle of the open label phase contains a loading dose of 10 mg/kg on days 1, 3, and 5. This will allow for subjects from all three dosing cohorts to receive a loading dose of 10mg/kg while maintaining the blind.
    Tutti i soggetti che hanno completato i 9 cicli di trattamento assegnato in origine potranno passare allo studio di estensione in aperto e riceveranno 10 mg/kg di PRM-151 ogni 4 settimane.
    Il primo ciclo della fase in aperto contiene una dose di carico di 10 mg/kg nei giorni 1, 3 e 5. Ciò consentirà ai soggetti di tutte e tre le coorti di ricevere un dosaggio di carico di 10 mg/kg mantenendo lo studio in cieco.
    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 Decision2017-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
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