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    EudraCT Number:2015-001909-14
    Sponsor's Protocol Code Number:APL-B-021-13
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-30
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzechia - SUKL
    A.2EudraCT number2015-001909-14
    A.3Full title of the trial
    A Phase II Study of Plitidepsin in Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
    Klinické hodnocení fáze II přípravku plitidepsin u pacientů s recidivujícím nebo rezistentním angioimunoblastickým T-buněčným lymfomem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study of Plitidepsin in Patients with Angioimmunoblastic T-cell Lymphoma.
    Klinické hodnocení fáze II přípravku plitidepsin u pacientů s angioimunoblastickým T-buněčným lymfomem
    A.4.1Sponsor's protocol code numberAPL-B-021-13
    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 SponsorPharma Mar, S.A.
    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 supportPharma Mar, S.A.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharma Mar, S.A.
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressAvd. De Los Reyes, no 1 Pol. Ind. La Mina
    B.5.3.2Town/ cityColmenar Viejo (Madrid)
    B.5.3.3Post code28770
    B.5.4Telephone number3491846 60 00
    B.5.5Fax number3491846 60 03
    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 nameAplidin
    D.3.4Pharmaceutical form Powder and solvent for 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 INNplitidepsin
    D.3.9.3Other descriptive namePLITIDEPSIN
    D.3.9.4EV Substance CodeSUB31204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.
    Recidivující nebo rezistentní angioimunoblastický T-buněčný lymfom.
    E.1.1.1Medical condition in easily understood language
    Angioimmunoblastic T-cell Lymphoma.
    Angioimunoblastický T-buněčný lymfom.
    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 10002453
    E.1.2Term Angioimmunoblastic T-cell lymphoma refractory
    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 evaluate the efficacy of plitidepsin on the basis of overall response rate (ORR) in patients with relapsing/refractory angioimmunoblastic T-cell lymphoma (AITL).
    E.2.2Secondary objectives of the trial
    •To evaluate other efficacy endpoints (time-to-event parameters:
    duration of response [DoR], progression-free survival [PFS], PFS at 6/12
    months [PFS6/PFS12], intrapatient PFS/TTP, overall survival [OS] and
    OS at 6/12 months [OS6/OS12]).
    •To evaluate the safety profile of plitidepsin in this patient population.
    •To characterize the pharmacokinetics (PK) of plitidepsin.
    •To identify biomarkers that may be clinical endpoint surrogates for
    future plitidepsin studies or that may be predictive of plitidepsin activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Voluntary written informed consent of the patient (both to participate
    in the study and to provide biopsy samples) obtained before any studyspecific
    2)Age ≥ 18 years.
    3)Eastern Cooperative Oncology Group (ECOG) performance status (PS)
    ≤ 2.
    4)Life expectancy ≥ 3 months.
    5)Histologically confirmed diagnosis of R/R AITL (eligibility needs to be
    confirmed by central pathological review.*)
    6)At least a two-week washout period since the end of the last therapy
    (six weeks for a prior nitrosourea-containing regimen), recovery to
    grade ≤ 1 from any non-hematological adverse event (AE) derived from
    previous treatment (excluding alopecia).
    7)Adequate bone marrow (BM), renal, hepatic, and metabolic function
    (assessed ≤ 14 days before inclusion in the study):
    a)Absolute neutrophil count (ANC) ≥ 1.0 × 109/L.
    Screening of ANC should be independent of granulocyte-colony
    stimulating factor (G-CSF) support for at least one week and of
    pegylated G-CSF for at least two weeks.
    b)Platelet count ≥ 75 × 109/L.
    c)Hemoglobin ≥ 9 g/dL.
    Patients may receive red blood cells (RBC) and/or erythropoietin (EPO)
    and/or platelet transfusions in accordance with institutional guidelines.
    d)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)
    ≤ 3.0 × the upper limit of normal (ULN).
    e)Total bilirubin ≤ 1.5 × ULN.
    f)Alkaline phosphatase (ALP) ≤ 3.0 × ULN (< 5 × ULN if isolated ALP
    increase, i.e., without ALT/AST or bilirubin increase).
    g)Calculated creatinine clearance (CrCL) ≥ 30 mL/minute (Cockcroft-
    Gault formula).
    h)Creatine phosphokinase (CPK) ≤ 2.5 × ULN.
    i)Albumin ≥ 2.5 g/dL.
    8)Left ventricular ejection fraction (LVEF) by echocardiogram
    (ECHO) or multiple-gated acquisition (MUGA) scan within
    normal range (according to institutional standards).
    * Patient inclusion can be approved based on local histopathological
    report(s). Eligibility will be confirmed using diagnosis and/or relapse
    biopsy specimens submitted for central pathological review prior to each
    futility analysis/end of the study.
    1) Dobrovolný písemný informovaný souhlas pacienta (s účastí v klinickém hodnocení a s poskytnutím bioptických vzorků) získaný ještě před vyšetřeními v rámci klinického hodnocení.
    2) Věk ≥ 18 let.
    3) Výkonnost ≤ 2 podle stupnice Východní skupiny pro spolupráci v onkologii (ECOG).
    4) Očekávaná doba dožití ≥ 3 měsíce.
    5) Histologicky potvrzená diagnóza R/R AITL (Způsobilost musí být potvrzena centrálním patologem. Zařazení pacienta do klinického hodnocení může být schváleno na základě místní histopatologické zprávy. Způsobilost bude potvrzována na základě bioptických vzorků získaných při stanovení diagnózy a/nebo při relapsu onemocnění a poskytnutých k vyhodnocení centrálním patologem před každou analýzou neúčinnosti/na konci klinického hodnocení.).
    6) Minimálně dvoutýdenní vymývací fáze od konce poslední léčby (šestitýdenní v případě režimu obsahujícího nitrosomočovinu), zotavení z případné nehematologické nežádoucí příhody (AE) vyvolané předchozí léčbou (kromě alopecie) na stupeň ≤ 1.
    7)Přiměřená funkce kostní dřeně, ledvinová, jaterní a metabolická funkce (posuzovaná ≤ 14 dnů před zařazením do klinického hodnocení):
    a)Absolutní počet neutrofilů (ANC) ≥ 1,0 x 109/l.
    Hodnota ANC by měla být stanovena nezávisle na podpůrném podávání faktoru stimulujícího granulocytární kolonie (G-CSF) po dobu alespoň jednoho týdne a pegylovaného G-CSF po dobu alespoň dvou týdnů.
    b)Počet krevních destiček ≥ 75 × 109/l.
    c)Hemoglobin ≥ 9 g/dl.
    Pacienti mohou dostávat transfuze červených krvinek a/nebo erytropoetinu (EPO) a/nebo krevních destiček v souladu se směrnicemi platnými v místním zdravotnickém zařízení.
    d)Aspartát aminotransferáza (AST) nebo alanin aminotransferáza (ALT) ≤ trojnásobek horní hranice normálního rozmezí.
    e)Celkový bilirubin ≤ 1,5násobek horní hranice normálního rozmezí.
    f)Alkalická fosfatáza (ALP) ≤ trojnásobek horní hranice normálního rozmezí (< pětinásobek horní hranice normálního rozmezí, pokud se jedná o ojedinělé zvýšení hodnoty ALP, tj. bez zvýšení hodnot ALT/AST nebo bilirubinu).
    g)Vypočítaná clearance kreatininu (CrCL) ≥ 30 ml/min (Cockcroftův-Gaultův vzorec).
    h)Kreatin fosfokináza (CPK) ≤ 2,5násobek horní hranice normálního rozmezí.
    i)Albumin ≥ 2,5 g/dl.
    8)Ejekční frakce levé komory (LVEF) na echokardiogramu (ECHO) nebo při vícenásobném akvizičním snímkování (MUGA) v normálním rozmezí (podle metodiky zdravotnického zařízení).
    E.4Principal exclusion criteria
    1)Prior treatment with plitidepsin.
    2)Concomitant diseases/conditions:
    a)History or presence of angina, myocardial infarction, clinically relevant
    valvular heart disease, uncontrolled hypertension, or congestive heart
    failure within the previous 12 months.
    b)Symptomatic arrhythmia (excluding grade ≤ 2 anemia-related sinusal
    tachycardia) or any arrhythmia requiring ongoing treatment, and/or
    prolonged grade ≥ 2 QT-QTc, or presence of unstable atrial fibrillation.
    Patients with stable atrial fibrillation on treatment are allowed provided
    they do not meet any other cardiac or prohibited drug exclusion
    c)Active uncontrolled infection. Active hepatitis B or C virus (HBV or
    HCV), or human immunodeficiency virus (HIV) infection.
    d)Morphological or cytological features of myelodysplasia and/or postchemotherapy
    aplasia on BM assessment.
    e)Myopathy > grade 2 or any clinical situation that causes significant
    and persistent elevation of CPK (> 2.5 × ULN in two different
    determinations performed one week apart).
    f)Limitation of the patient's ability to comply with the treatment or
    follow-up requirements.
    g)Diagnosis of another invasive malignancy unless free of disease for at least three years following therapy with curative intent. Patients with
    early-stage basal cell or squamous cell skin cancer, cervical
    intraepithelial neoplasia, cervical carcinoma in situ, or superficial
    bladder cancer, may be eligible to participate at the Investigator's
    h)Any other major illness that, in the Investigator's judgment, will
    substantially increase the risk associated with the patient's participation
    in this study.
    3)Central nervous system (CNS) involvement.
    4)Women who are pregnant or breast feeding. Fertile patients (men and
    women) who are not using an effective method of contraception. All
    patients (men and women) must agree to use an effective contraceptive
    measure (if applicable) up to six months after treatment discontinuation.
    5)Concomitant medications that include corticosteroids, chemotherapy,
    or other therapy that is or may be active against AITL, within the two
    weeks prior to treatment start. Concurrent corticosteroids are allowed,
    provided they are administered at an equivalent prednisone dose of ≤ 10 mg daily, as premedication for blood products and/or for the relief of the symptoms derived from the disease.
    6)Major upper gastrointestinal bleeding episode occurring during the
    previous year before screening.
    7)Known hypersensitivity to any of plitidepsin’s formulation components (see Study Drug Formulation).
    1)Předchozí souběžná léčba plitidepsinem.
    2)Souběžná onemocnění / souběžné stavy:
    a)Anamnéza nebo přítomnost anginy pectoris, infarktu myokardu, klinicky významného onemocnění srdečních chlopní, nezvládaného vysokého krevního tlaku nebo městnavého srdečního selhání v posledních 12 měsících.
    b)Symptomatická srdeční arytmie (s výjimkou sinusové tachykardie stupně ≤ 2 související s anémií) nebo jakékoli poruchy srdečního rytmu vyžadující další léčbu a/nebo dlouhodobé prodloužení intervalu QT-QTc stupně ≥ 2 nebo nestabilní fibrilace síní. Pacienti se stabilní fibrilací síní podstupující léčbu se budou moci klinického hodnocení zúčastnit, pokud nebudou splňovat žádné jiné vylučovací kritérium týkající se srdečních onemocnění nebo zakázaných léků.
    c)Nezvládaná aktivní infekce. Aktivní infekce virem hepatitidy B nebo C (HBV nebo HCV) nebo virem lidské imunitní nedostatečnosti (HIV).
    d)Morfologické nebo cytologické vlastnosti myelodysplazie a/nebo postchemoterapeutická aplazie při vyšetření kostní dřeně.
    e)Myopatie > stupeň 2 nebo případný jiný klinický stav, který způsobuje významné a přetrvávající zvýšení hodnoty CPK (> 2,5násobek horní hranice normálního rozmezí při dvou vyšetřeních v odstupu jednoho týdne).
    f)Omezená schopnost pacienta dodržovat požadavky léčby nebo sledování po léčbě.
    g)Diagnóza jiného invazivního zhoubného onemocnění, pokud pacient není bez onemocnění už alespoň tři roky po léčbě s léčebným záměrem. Klinického hodnocení se podle uvážení zkoušejícího lékaře budou moci účastnit pacienti s bazocelulárním nebo spinocelulárním karcinomem v raném stadiu, s cervikální intraepiteliální neoplazií, s cervikálním karcinomem in situ nebo s povrchovým karcinomem močového měchýře.
    h)Jakékoli závažné onemocnění, které by podle úsudku zkoušejícího lékaře mohlo výrazně zvyšovat rizika spojená s účastí pacienta v tomto klinickém hodnocení.
    3)Zasažení centrální nervové soustavy (CNS).
    4)Těhotné nebo kojící ženy. Fertilní pacienti (muži i ženy) ne(po)užívající účinnou antikoncepci. Všichni pacienti (muži i ženy) se proto budou muset zavázat, že budou ještě šest měsíců po skončení léčby (po)užívat účinnou antikoncepci (bude-li to v jejich případě relevantní).
    5)Souběžná léčba v posledních dvou týdnech před zahájením hodnocené léčby zahrnující podávání kortikosteroidů, chemoterapie nebo jiných léků, které působí nebo by mohly působit proti AITL. Současné podávání kortikosteroidů je dovoleno za předpokladu, že jsou podávány v dávce ekvivalentní ≤ 10 mg prednisonu denně jako premedikace pro krevní přípravky a/nebo pro úlevu od příznaků odvozených od onemocnění.
    6)Závažné krvácení do horní části zažívacího traktu v posledním roce před vstupními vyšetřeními.
    7)Známá přecitlivělost na jakoukoli složku lékové formy plitidepsinu (viz složení hodnoceného přípravku).
    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR), defined as the percentage of patients with remission, either complete (CR) or partial remission (PR), according to the Lugano classification response criteria per independent review.
    An external IRC will assign the objective response and a progression or censoring date for each patient according to a predefined algorithm provided in a separate charter.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two futility analyses of the primary endpoint (ORR according to the Lugano classification criteria and per IRC) are planned around six months after approximately 25% and 50% of eligible patients (i.e., 15 and 30 patients respectively with AITL confirmed by central pathological review) have been treated.
    E.5.2Secondary end point(s)
    *ORR per Investigator assessment (IA).
    *CR rate, defined as the percentage of patients with complete remission according to the Lugano classification per IRC and per IA.
    *Duration of response (DoR), defined as the time from the date when the remission criteria (PR or CR, whichever is first achieved) are fulfilled to the first date when PD, recurrence or death (due to any cause) is documented. Response will be assessed according to Lugano classification and per IRC and IA.
    *Progression-free survival (PFS), defined as the time from the date of first drug administration to the date of PD, death (of any cause), or last tumor evaluation per IRC and IA.
    *Progression-free survival at 6/12 months (PFS6/PFS12), defined as the Kaplan-Meier estimate of the percentage of patients who are progression-free at six/twelve months after the first drug administration per IRC and IA.
    *Intrapatient PFS/TTP, defined as the ratio of PFS achieved with the experimental treatment versus prior last TTP in the R/R setting.
    *Overall survival (OS), defined as the time from the date of the first dose to the date of death (of any cause) or last patient contact.
    *Overall survival at 6/12 months (OS6/OS12), defined as the Kaplan-Meier estimate of the percentage of patients who are alive at six/twelve months after first drug administration.
    *Treatment safety [AEs, serious adverse events (SAEs) and laboratory abnormalities] graded according to the NCI-CTCAE, v.4. Dose reductions, omitted doses or cycle delays due to treatment-related AEs, and reasons for treatment discontinuations will be analyzed.
    *Pharmacokinetics (PK), samples for PK analysis will be obtained during Cycle 1 exclusively.
    *Exploratory Biomarker Analysis, biopsy samples (initial and relapse) and blood samples will be analyzed in order to examine any correlation of efficacy with molecular markers related to the mechanism of action of plitidepsin or to the pathogenesis of the disease.

    A total of 60 patients with AITL confirmed by central pathological review will be treated, 19 or more responders will be needed to get an overall estimate for response rate higher than 30% and its lower limit for the 95% confidence interval (CI) greater than 20% (31.7% CI95% 20.3?45.0% following the binomial distribution).

    E.5.2.1Timepoint(s) of evaluation of this end point
    During the study and in the Independent Review Committee meetings.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker Analysis.
    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. 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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
    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
    12 months after the last patients inclusion. If there are patients still being treated at the planned cutoff date, the actual cutoff date will be the date when those patients have completed the ongoing treatment cycle and the corresponding EOT visit.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 36
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 60
    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)
    After EOT, patients will be followed every four weeks until resolution of all toxicities (if any). Patients who discontinue treatment without disease progression will be followed every four months (+ two weeks) for the first two years of follow-up, and every six months (+ two weeks) thereafter unless clinically indicated, until PD, start of other antitumor therapy, death or the date of study termination (clinical cutoff), whichever occurs first.
    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 Decision2016-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-07-02
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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