Clinical trial • Phase II • Oncology|Haematology

IMATINIB for Acute lymphoblastic leukaemia (Philadelphia chromosome-positive)

Phase II trial of IMATINIB for Acute lymphoblastic leukaemia (Philadelphia chromosome-positive).

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Acute lymphoblastic leukaemia (Philadelphia chromosome-positive)
Trial Stage
Phase II
Drug Modality
Small molecule|Bispecific antibody

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
08-11-2024

Trial design

Randomised, imatinib (imatinib, oral film-coated tablet; max daily dose listed 600 mg; schedule not specified)-controlled Phase II trial in Germany.

Randomised
Yes
Comparator
IMATINIB (IMATINIB, oral film-coated tablet; max daily dose listed 600 mg; schedule not specified)
Target Sample Size
208

Eligibility

Recruits 208 No vulnerable population selected (isVulnerablePopulationSelected=false). Trial enrols adults (>=18 years). Signed written informed consent is required from participants; no assent or paediatric consent procedures described..

Pregnancy Exclusion
Negative pregnancy test in women of childbearing potential
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected=false). Trial enrols adults (>=18 years). Signed written informed consent is required from participants; no assent or paediatric consent procedures described.

Inclusion criteria

  • {"criterion_text":"- Male or female patients >= 18 years, <=65 years, Philadelphia chromosome or BCR::ABL1 positive ALL, Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib), ECOG performance status ≤2, Signed written inform consent, Molecular evaluation for BCR::ABL1 performed, Negative pregnancy test in women of childbearing potential, Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index <1%). Effective Contraception is defined as: o abstinence o a hormonal contraceptive method (birth control pills, intrauterine spiral, vaginal ring, contraceptive patches, depot implants or injections) in combination with barrier methods (condoms, cervical cap, diaphragm with spermicides) o Vasectomy in patients or male partners Women of childbearing potential are defined as mature women without hysterectomie or surgical sterilization or women without menopause. Menopause means without without menstruation for natural reasons for one year, Normal serum levels > LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication, Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis, Normal QTcF interval ≤450 ms for males and ≤470 ms for females, Signed and dated written informed consent is available, Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)"}

Exclusion criteria

  • {"criterion_text":"- History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions: o Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease o Adequately treated cervical carcinoma in situ without evidence of disease o Adequately treated breast ductal carcinoma in situ without evidence of disease o Prostatic intraepithelial neoplasia without evidence of prostate cancer, Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab, Patient previously treated with tyrosine kinase inhibitors, Nursing women, Known impaired cardiac function, including any of the following: o LVEF < 40% o Complete left bundle branch block o Right bundle branch block plus left anterior hemiblock, bifascicular block o History of or presence of clinically significant ventricular or atrial tachyarrhythmias o Clinically significant resting bradycardia (< 50 beats per minute) o Congenital long QT syndrome or QTcF >470 msec for females and >450 msec for males on screening ECG. If QTc > 470 msec for females and > 450 msec for males and electrolytes are not within normal ranges before ponatinib dosing, electrolytes should be corrected and then the patient rescreened for QTcF crite- rion. o Myocardial infarction within 12 months prior to starting study treatment o Other clinically significant heart disease (e.g. unstable angina, congestive heart failure, uncontrolled hypertension), Symptomatic peripheral vascular disease, Any history of ischemic stroke or transient ischemic attacks (TIAs), Uncontrolled hypertriglyceridaemia, History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, cerebrovascular ischemia/haemorrhage, severe brain injuries, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis (with exception of CNS leukemia that is well controlled with intrathecal therapy), History or active relevant autoimmune disease, Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation, Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not man- datory) or active infection with Hepatitis B or C, History of pancreatitis within 6 months previous to start of treatment within the trial, Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study, Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional upper limit of noral or > 5 times ULN if considered due to leukemia, Total bilirubin > 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert / M. Meulengracht, Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections, Inability to understand and/or unwillingness to sign a written informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Probability of overall survival at 2,3 and 4 years from randomization I in patients with mo- lecular remission after consolidation 1 comparing a combination treatment of TKI, Blina- tumomab and chemotherapy versus EOT with indication for SCT","definition_or_measurement_approach":"Overall survival probability at 2, 3 and 4 years from randomization in patients with molecular remission after consolidation 1, comparing combination TKI/Blinatumomab/chemotherapy versus end-of-therapy strategy with indication for SCT."}

Secondary endpoints

  • {"endpoint_text":"- Rate of molecular complete remission at week 11 after consolidation with chemotherapy in combination with Ponatinb versus Imatinib","definition_or_measurement_approach":"Rate of molecular complete remission measured at week 11 after consolidation with chemotherapy when given in combination with Ponatinib versus Imatinib."}

Recruitment

Registry Or Advocacy Recruitment
True, German Multicenter Study Group for Adult ALL (GMALL) registry
Planned Sample Size
208
Recruitment Window Months
84
Consent Approach
Signed written informed consent required from adult participants (>=18). Subject information / ICF documents available (e.g. 'L1_ICF_Main_Adult_TC'). No assent or paediatric consent described; languages not specified.

Geography

Total Number Of Sites
80
Total Number Of Participants
208

Germany

Earliest CTIS Part Ii Submission Date
05-11-2024
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
513
Number Of Sites
80
Number Of Participants
208

Sites

Site Name
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH
Department Name
Klinik für Hämatologie und Onkologie – Studienzentrum
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Medizinische Klinik II
Contact Person Name
Christoph Faul
Site Name
Kliniken Suedostbayern AG
Department Name
Onkologie – Hämatologie
Contact Person Name
Florian Zettl
Contact Person Email
florian.zettl@kliniken-sob.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik Innere Medizin C / Hämatologie und Onkologie
Contact Person Name
Christian Spaeth
Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Klink für Hämatologie, Onkologie und klinische Immunologie
Contact Person Name
Kathrin Nachtkamp
Site Name
Klinikum Bayreuth GmbH
Department Name
Hämatologie und internistische Onkologie
Contact Person Name
Alexander Kiani
Site Name
KRH Klinikum SILOAH
Department Name
Hämatologie, Onkologie und Immunologie
Contact Person Name
Martin Müller
Contact Person Email
martin.mueller@krh.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hämatologie u. internistische Onkologie Medizinische Klinik 5
Contact Person Name
Bernd Spriewald
Contact Person Email
bernd.spriewald@uk-erlangen.de
Site Name
Klinikum Nuernberg
Department Name
Abteilung für Stammzelltransplantation und Zelltherapie
Contact Person Name
Knut Wendelin
Site Name
Klinikum Ernst von Bergmann gGmbH
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Su-Hyeon Kim
Contact Person Email
suhyeon.kim@klinikumevb.de
Site Name
Maerkische Kliniken GmbH
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Monika Schwalenberg
Site Name
St.-Antonius-Hospital gGmbH
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Peter Staib
Contact Person Email
peter.staib@sah-eschweiler.de
Site Name
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Contact Person Name
Roland Schroers
Contact Person Email
roland.schroers@rub.de
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik für Innere Medizin I
Contact Person Name
Ralph Wäsch
Site Name
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
Department Name
Klinik für Innere Medizin II Onkologie/Hämatologie
Contact Person Name
Paul Graf La Rosee
Contact Person Email
paul.larosee@sbk-vs.de
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
Klinik für Onkologie und Palliativmedizin
Contact Person Name
Daniel Schöndube
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medizinische Klinik und Poliklinik
Contact Person Name
Franziska Modemann
Contact Person Email
f.westendorf@uke.de
Site Name
Klinikum Kassel GmbH
Department Name
Klinik für Hämatologie, Onkologie und Immunologie
Contact Person Name
Daniela Dörfel
Contact Person Email
daniela.doerfel@gnh.net
Site Name
Universitaetsklinikum Augsburg
Department Name
Universitätsklinikum Augsburg A.ö.R.
Contact Person Name
Andreas Rank
Contact Person Email
andreas.rank@uk-augsburg.de
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
Krankenhaus Barmherzige Brüder Regensburg
Contact Person Name
Bernhard Heilmeier
Site Name
Universitaetsmedizin Goettingen
Department Name
Hämatologie und Medizinische Onkologie
Contact Person Name
Wolfram Jung
Site Name
Katholisches Karl-Leisner-Klinikum
Department Name
Hämatologie / Onkologie
Contact Person Name
Volker Runde
Contact Person Email
volker.runde@kkle.de
Site Name
Klinikum Oldenburg AöR
Department Name
Universitätsmedizin Oldenburg Universitätsklinik für Innere Medizin -Onkologie und Hämatologie
Contact Person Name
Andreas Voss
Site Name
Heinrich-Braun-Klinikum Zwickau gGmbH
Department Name
Heinrich-Braun-Klinikum gemeinnützige GmbH Standort Zwickau
Contact Person Name
Sara Hilber
Contact Person Email
sara.hilber@hbk-zwickau.de
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Klinik für Hämatologie, Onkologie Und Palliativmedizin
Contact Person Name
Maike De Wit
Contact Person Email
maike.dewit@vivantes.de
Site Name
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
Department Name
Gesellschaft für Medizinische Forschung mbH
Contact Person Name
Sonja Martin
Contact Person Email
sonja.martin@rbk.de
Site Name
Klinikum Aschaffenburg-Alzenau gGmbH
Department Name
Klinikum Aschaffenburg
Contact Person Name
Simone Liebler
Site Name
Staedtisches Klinikum Dessau
Department Name
Klinik für Innere Medizin
Contact Person Name
Gerhard Behre
Site Name
Asklepios Klinik St George
Department Name
Hämatologie, Onkologie und Stammzelltransplantation
Contact Person Name
Ahmet Elmaagacli
Contact Person Email
a.elmaagacli@asklepios.com
Site Name
Kliniken Maria Hilf GmbH Moenchengladbach
Department Name
Klinik für Hämatologie, Onkologie und Gastroenterologie
Contact Person Name
Ullrich Graeven
Contact Person Email
ullrich.graeven@mariahilf.de
Site Name
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH
Department Name
Klinik für Hämatologie, Internistische Onkologie & Stammzelltransplantation
Contact Person Name
Peter Reimer
Contact Person Email
p.reimer@kem-med.com
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik V
Contact Person Name
Simon Raffel
Site Name
Klinikum Darmstadt GmbH
Department Name
Klinikum Darmstadt GmbH
Contact Person Name
Bernhard Helga
Site Name
Diakonie-Klinikum Schwaebisch Hall gGmbH
Department Name
Onkologie, Hämatologie und Palliativmedizin
Contact Person Name
Michael Medinger
Contact Person Email
michael.medinger@diakoneo.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation
Contact Person Name
Jens Panse
Contact Person Email
jpanse@ukaachen.de
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
III. Medizinischen Klinik und Poliklinik
Contact Person Name
Hans-Joachim Beck
Site Name
Franziskus Hospital Harderberg
Department Name
Zentrum für Internistische Onkologie und Hämatologie
Contact Person Name
Rudolf Peceny
Site Name
Klinikum Mutterhaus der Borromaeerinnen gGmbH
Department Name
Klinikum Mutterhaus der Borromäerinnen gGmbH
Contact Person Name
Rolf Mahlberg
Contact Person Email
mahlberg@mutterhaus.de
Site Name
Klinikum Passau Service GmbH
Department Name
II.Medizinische Klinik
Contact Person Name
Thomas Südhoff
Site Name
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Department Name
Medizinische Klinik III – Onkologie/Hämatologie
Contact Person Name
Dirk Strumberg
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
Medizinische Klinik 1
Contact Person Name
Maher Hanoun
Site Name
HELIOS Klinikum Berlin-Buch GmbH
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Contact Person Name
Judith Niederland
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin III
Contact Person Name
Andreas Viardot
Site Name
Medizinische Hochschule Hannover
Department Name
Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Contact Person Name
Felicitas Thol
Contact Person Email
thol.felicitas@mh-hannover.de
Site Name
Vincentius-Diakonissen-Kliniken gAG
Department Name
Hämatologie, Onkologie, Immunologie, Palliativmedizin
Contact Person Name
Martina Gnadler
Site Name
University Hospital Cologne AöR
Department Name
Centrum für Integrierte Onkologie (CIO)
Contact Person Name
Boris Böll
Contact Person Email
boris.boell@uk-koeln.de
Site Name
Philipps-Universitaet Marburg
Department Name
Hämatologie-Onkologie-Immunologie
Contact Person Name
Andreas Burchert
Contact Person Email
burchert@staff.uni-marburg.de
Site Name
Otto Von Guericke Universitaet Magdeburg
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Ana Maria Waldleben
Contact Person Email
ana.waldleben@med.ovgu.de
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik III
Contact Person Name
Christoph Schünemann
Contact Person Email
c.schuenemann@skbs.de
Site Name
Johanniter GmbH
Department Name
Johanniter-Krankenhaus und Waldkrankenhaus Bonn
Contact Person Name
Yon-dschun Ko
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin I
Contact Person Name
Jörg Bittenbring
Site Name
HELIOS Klinikum Duisburg GmbH
Department Name
Klinik für Hämatologie, Onkologie und klinische Immunologie
Contact Person Name
Stela Theodoropoulou
Site Name
Katholisches Krankenhaus Hagen gGmbH
Department Name
Hämatologie und Onkologie
Contact Person Name
Doris Krämer
Contact Person Email
kraemerd@kkh-hagen.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Medizinische Klinik und Poliklinik II
Contact Person Name
Max Topp
Contact Person Email
topp_m@ukw.de
Site Name
Staedtisches Klinikum Karlsruhe gGmbH
Department Name
Med. Klinik III
Contact Person Name
Lukas Kündgen
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Medizinische Klinik II Hämatologie und Onkologie
Contact Person Name
Lars Fransecky
Contact Person Email
lars.fransecky@uksh.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Med. Kl. m. S. Hämatologie, Onkologie und Tumorimmunologie
Contact Person Name
Jörg Westermann
Contact Person Email
joerg.westermann@charite.de
Site Name
Universitaet Leipzig
Department Name
Klinik und Poliklinik für Hämatologie, Zelltherapie, Hämostaseologie und Infektiologie
Contact Person Name
Georg-Klaus Franke
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A
Contact Person Name
Klaus Wethmar
Contact Person Email
klaus.wethmar@ukmuenster.de
Site Name
Klinikum Fulda gAG
Department Name
Innere Medizin und Hämatologie und internistische Onkologie
Contact Person Name
Philippe Kostrewa
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin II
Contact Person Name
Inken Hilgendorf
Site Name
Heidelberg University
Department Name
III. Med. Klinik
Contact Person Name
Daniela Heidenreich
Contact Person Email
daniela.heidenreich@umm.de
Site Name
Barmherzige Brueder Trier gGmbH
Department Name
Hämatologisches Zentrum
Contact Person Name
Iordanis Deligiannis
Contact Person Email
i.deligiannis@bbt-gruppe.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik III
Contact Person Name
Lino Teichmann
Contact Person Email
lino.teichmann@ukbonn.de
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik für Innere Medizin, Hämatologie|Onkologie und Palliativmedizin
Contact Person Name
Bettina Zinngrebe
Contact Person Email
bettina.zinngrebe@evkb.de
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
Universitätsklinik und Poliklinik für Innere Medizin IV
Contact Person Name
Nadja Jäkel
Contact Person Email
nadja.jaekel@uk-halle.de
Site Name
Kath. St. Paulus GmbH
Department Name
Abteilung für Klinische Forschung Bereich Onkologische Studien
Contact Person Name
Heidrun Hindahl
Site Name
Vivantes Netzwerk fuer Gesundheit GmbH
Department Name
Hämatologie und Onkologie
Contact Person Name
Matthias Hackenthal
Site Name
Kommunale Traegergesellschaft Cottbus mbH
Department Name
Thiem-Research GmbH
Contact Person Name
Martin Schmidt-Hieber
Contact Person Email
m.schmidt_hieber@mul-ct.de
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Medizin III
Contact Person Name
Hendrik Poeck
Contact Person Email
hendrik.poeck@ukr.de
Site Name
Klinikum Idar-Oberstein GmbH
Department Name
Klinikum Idar-Oberstein GmbH Med. Management
Contact Person Name
Johannes Schneider
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie
Contact Person Name
Stefan Schwartz
Contact Person Email
stefan.schwartz@charite.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Contact Person Name
Thomas Michael Schröder
Contact Person Email
thomas.schroeder@uk-essen.de
Site Name
Klinikum Dortmund gGmbH
Department Name
Klinikum Dortmund gGmbH
Contact Person Name
Volker Rethwisch
Contact Person Email
volker.rethwisch@klinikumdo.de
Site Name
Diakonie-Klinikum Stuttgart Diakonissenkrankenhaus und Paulinenhilfe gGmbH
Department Name
Diakonie-Klinikum Stuttgart
Contact Person Name
Jochen Greiner
Contact Person Email
greiner@diak-stuttgart.de
Site Name
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Department Name
Klinik für Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Jan Schleicher
Site Name
Goethe University Frankfurt
Department Name
Hämatologie/Onkologie
Contact Person Name
Fabian Lang
Contact Person Email
f.lang@med.uni-frankfurt.de
Site Name
Marien Hospital Duesseldorf GmbH
Department Name
Klinik für Onkologie, Hämatologie und Palliativmedizin
Contact Person Name
Stefanie Gröpper
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
Zentrum für klinische Studien der Klinik und Poliklinik für Innere Medizin III
Contact Person Name
Folker Schneller
Contact Person Email
folker.schneller@mri.tum.de
Site Name
Ortenau Klinikum
Department Name
ORTENAU KLINIKUM Offenburg-Kehl
Contact Person Name
Carsten Schwänen
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Contact Person Name
Lisa Heberling
Contact Person Email
lisa.heberling@ukdd.de
Site Name
Johanniter-Kliniken Hamm GmbH
Department Name
Klinik für Innere Medizin II
Contact Person Name
Alexander Baraniskin

Sponsor

Primary sponsor

Full Name
Goethe University Frankfurt
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
IMATINIB
Active Substance
IMATINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
600 mg (maxDailyDoseAmount)
Investigational Product Name
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
Active Substance
BLINATUMOMAB
Modality
Bispecific antibody
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
EU marketing authorisation EU/1/15/1047/001
Maximum Dose
28 µg (maxDailyDoseAmount)
Investigational Product Name
Iclusig 45 mg film-coated tablets
Active Substance
PONATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
EU marketing authorisation EU/1/13/839/003
Maximum Dose
45 mg (maxDailyDoseAmount)
Combination Treatment
Yes

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