Clinical trial • Phase III • Oncology|Rare Disease

loncastuximab tesirine for Diffuse large B-cell lymphoma|Relapsed or refractory diffuse large B-cell lymphoma

Phase III trial of loncastuximab tesirine for Diffuse large B-cell lymphoma|Relapsed or refractory diffuse large B-cell lymphoma.

Overview

Trial Therapeutic Area
Oncology|Rare Disease
Trial Disease
Diffuse large B-cell lymphoma|Relapsed or refractory diffuse large B-cell lymphoma
Trial Stage
Phase III
Drug Modality
ADC|Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
30-01-2024
First CTIS Authorization Date
07-03-2024

Trial design

Randomised, open-label, soc (r-gemox) — r-gemox (rituximab [truxima] with gemcitabine [gemcitabine] and oxaliplatin [oxaliplatin]); product entries list typical dosing maxima (rituximab 375 mg/m2, gemcitabine up to 1000 mg/m2, oxaliplatin up to 100 mg/m2) but the protocol does not specify a single uniform schedule in the ctis record provided.-controlled Phase III trial across 43 sites in Netherlands, Poland, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
SoC (R-GemOx) — R-GemOx (rituximab [Truxima] with gemcitabine [GEMCITABINE] and oxaliplatin [OXALIPLATIN]); product entries list typical dosing maxima (rituximab 375 mg/m2, gemcitabine up to 1000 mg/m2, oxaliplatin up to 100 mg/m2) but the protocol does not specify a single uniform schedule in the CTIS record provided.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
190
Trial Duration For Participant
1460

Eligibility

Recruits 190 Vulnerable population selected. Informed consent is required from participants (trial enrolment restricted to adults aged 18 years or older). Multiple country-specific subject information and informed consent form (SIS-ICF) documents are listed (e.g. Main Randomized, Safety Run-In, Pregnancy/Partner forms) in various languages; no explicit assent or parental consent procedures for minors are described in the available records..

Pregnancy Exclusion
Breastfeeding or pregnant
Vulnerable Population
Vulnerable population selected. Informed consent is required from participants (trial enrolment restricted to adults aged 18 years or older). Multiple country-specific subject information and informed consent form (SIS-ICF) documents are listed (e.g. Main Randomized, Safety Run-In, Pregnancy/Partner forms) in various languages; no explicit assent or parental consent procedures for minors are described in the available records.

Inclusion criteria

  • {"criterion_text":"-Male or female patient aged 18 years or older"}
  • {"criterion_text":"-Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 12 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of giving informed consent until at least 7 months after the patient receives his last dose of study treatment."}
  • {"criterion_text":"-Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements"}
  • {"criterion_text":"-Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen"}
  • {"criterion_text":"-Not considered by the investigator to be a candidate for stem cell transplantation based on performance status, advanced age, and/or significant medical comorbidities such as organ dysfunction"}
  • {"criterion_text":"-Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET) – computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT"}
  • {"criterion_text":"-Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available) Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred."}
  • {"criterion_text":"-ECOG performance status 0-2"}
  • {"criterion_text":"-Adequate organ function as defined by screening laboratory values within the following parameters: a. Absolute neutrophil count ≥1000/µL (off growth factors at least 72 hours) b. Platelet count ≥100000/µL without transfusion within the past 2 weeks c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 × the upper limit of normal (ULN) d. Total bilirubin ≤1.5 × ULN (patients with known Gilbert's syndrome may have a total bilirubin up to ≤3 × ULN) e. Calculated creatinine clearance ≥30 mL/min by the Cockcroft and Gault equation Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility."}
  • {"criterion_text":"-Negative beta-human chorionic gonadotropin (β-hCG) pregnancy test within 7 days prior to start of study drug (Cycle 1 Day 1) for women of childbearing potential"}

Exclusion criteria

  • {"criterion_text":"-Previous treatment with loncastuximab tesirine"}
  • {"criterion_text":"-Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease"}
  • {"criterion_text":"-Human immunodeficiency virus (HIV) seropositive with any of the following: a. CD4+ T-cell (CD4+) counts <350 cells/µL b. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening c. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of screening d. HIV viral load ≥400 copies/mL"}
  • {"criterion_text":"-Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load"}
  • {"criterion_text":"-Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load"}
  • {"criterion_text":"-History of Stevens-Johnson syndrome or toxic epidermal necrolysis"}
  • {"criterion_text":"-Lymphoma with active CNS involvement, including leptomeningeal disease"}
  • {"criterion_text":"-Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)"}
  • {"criterion_text":"-Breastfeeding or pregnant"}
  • {"criterion_text":"-Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment"}
  • {"criterion_text":"-Major surgery within 4 weeks prior to start of study drug (Cycle 1 Day 1); radiotherapy, chemotherapy or other antineoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1), except shorter if approved by the Sponsor"}
  • {"criterion_text":"-Previous treatment with R-GemOx"}
  • {"criterion_text":"-Use of any other experimental medication within 14 days or 5 half- lives prior to start of study drug (Cycle 1 Day 1)"}
  • {"criterion_text":"-Received live vaccine within 4 weeks of Cycle 1 Day 1"}
  • {"criterion_text":"-Failure to recover to ≤Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non hematologic toxicity (except alopecia) due to previous therapy prior to screening"}
  • {"criterion_text":"-Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)"}
  • {"criterion_text":"-Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk"}
  • {"criterion_text":"-Known history of hypersensitivity to oxaliplatin or other platinum- based drugs, or gemcitabine, or rituximab, or any of their excipients"}
  • {"criterion_text":"-Known history of hypersensitivity to a CD19 antibody, loncastuximab tesirine (including SG3249) or any of its excipients, or history of or positive serum human ADA to a CD19 antibody"}
  • {"criterion_text":"-Pathologic diagnosis of Burkitt lymphoma"}
  • {"criterion_text":"-Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's medical monitor and Investigator agree and document should not be exclusionary"}
  • {"criterion_text":"-Autologous transplant within 30 days prior to start of study drug (Cycle 1 Day 1)"}
  • {"criterion_text":"-Allogeneic transplant within 60 days prior to start of study drug (Cycle 1 Day 1)"}
  • {"criterion_text":"-Active graft-versus-host disease"}
  • {"criterion_text":"-Post-transplantation lymphoproliferative disorders"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Progression-free survival (PFS) defined as the time between randomization and the first documentation of recurrence or progression by independent central review, or death from any cause","definition_or_measurement_approach":"PFS defined as time between randomization and first documentation of recurrence or progression by independent central review, or death from any cause (as stated in the protocol)"}

Recruitment

Planned Sample Size
190
Recruitment Window Months
57
Consent Approach
Informed consent is obtained from the participant (all participants aged ≥18). Country-specific SIS-ICF documents are available (Main Randomized, Safety Run-In, Pregnancy/Partner forms) in multiple languages including Dutch, French, Polish, Hungarian, Spanish, Italian and Czech; documents are provided per member state as listed in the CTIS record. No assent procedures for minors are described.

Geography

Total Number Of Sites
43
Total Number Of Participants
228

Netherlands

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
47
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Haga Hospital
Department Name
Department of Hematology
Principal Investigator Name
Lara Bohmer
Principal Investigator Email
l.h.bohmer@hagaziekenhuis.nl
Contact Person Name
Lara Bohmer
Contact Person Email
l.h.bohmer@hagaziekenhuis.nl
Site Name
Elisabeth-Tweesteden Ziekenhuis
Department Name
Department of Internal Medicine
Principal Investigator Name
Marc Durian
Principal Investigator Email
m.durian@etz.nl
Contact Person Name
Marc Durian
Contact Person Email
m.durian@etz.nl

Poland

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
15-03-2024
Processing Time Days
23
Number Of Sites
4
Number Of Participants
45

Sites

Site Name
Aidport Sp. z o.o.
Principal Investigator Name
Michal Kwiatek
Principal Investigator Email
michal.kwiatek@aidport.pl
Contact Person Name
Michal Kwiatek
Contact Person Email
michal.kwiatek@aidport.pl
Site Name
Szpitale Pomorskie Sp. z o.o.
Department Name
Oddzial Hematologii i Transplantologii Szpiku
Principal Investigator Name
Adam Witkowski
Principal Investigator Email
awitkowski@szpitalepomorskie.eu
Contact Person Name
Adam Witkowski
Site Name
Pratia S.A.
Principal Investigator Name
Wojciech Jurczak
Principal Investigator Email
wojciech.jurczak@pratia.com
Contact Person Name
Wojciech Jurczak
Contact Person Email
wojciech.jurczak@pratia.com
Site Name
Pratia Hematologia Sp. z o.o.
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
sgrosicki@wp.pl
Contact Person Name
Sebastian Grosicki
Contact Person Email
sgrosicki@wp.pl

Belgium

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
21-03-2024
Processing Time Days
29
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Gilles Crochet
Principal Investigator Email
Gilles.crochet@chuuclnamur.uclouvain.be
Contact Person Name
Gilles Crochet
Site Name
Algemeen Ziekenhuis Delta
Department Name
Hematology
Principal Investigator Name
Dries Deeren
Principal Investigator Email
dries.deeren@azdelta.be
Contact Person Name
Dries Deeren
Contact Person Email
dries.deeren@azdelta.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Hematology
Principal Investigator Name
Sylvia Snauwaert
Principal Investigator Email
sylvia.snauwaert@azsintjan.be
Contact Person Name
Sylvia Snauwaert
Contact Person Email
sylvia.snauwaert@azsintjan.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Hematology
Principal Investigator Name
Sarah Bailly
Principal Investigator Email
sarah.bailly@saintluc.uclouvain.be
Contact Person Name
Sarah Bailly

France

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
09-04-2024
Processing Time Days
48
Number Of Sites
4
Number Of Participants
42

Sites

Site Name
Centre Henri Becquerel
Department Name
Hématologie
Principal Investigator Name
Fabrice Jardin
Principal Investigator Email
fabrice.jardin@chb.unicancer.fr
Contact Person Name
Fabrice Jardin
Site Name
L'Hopital Prive Du Confluent
Department Name
Consultations d'Hématologie
Principal Investigator Name
Katell Le Du
Principal Investigator Email
katell.ledu@gmail.com
Contact Person Name
Katell Le Du
Contact Person Email
katell.ledu@gmail.com
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hématologie et thérapie cellulaire
Principal Investigator Name
Kamal Bouabdallah
Principal Investigator Email
krimo.bouabdallah@chu-bordeaux.fr
Contact Person Name
Kamal Bouabdallah
Site Name
Hopital Avicenne
Department Name
Service d’hépatologie
Principal Investigator Name
Thorsten Braun
Principal Investigator Email
thorsten.braun@aphp.fr
Contact Person Name
Thorsten Braun
Contact Person Email
thorsten.braun@aphp.fr

Hungary

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
07-03-2024
Processing Time Days
15
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Orszagos Onkologiai Intezet
Department Name
Hematology and Lymphoma department
Principal Investigator Name
Andras Masszi
Principal Investigator Email
masszi.andras@oncol.hu
Contact Person Name
Andras Masszi
Contact Person Email
masszi.andras@oncol.hu
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
Hematology
Principal Investigator Name
Tajti Balazs
Principal Investigator Email
tajtibalazs1985@gmail.com
Contact Person Name
Tajti Balazs
Contact Person Email
tajtibalazs1985@gmail.com
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Institute of Hematology and Infectology
Principal Investigator Name
Otto Csacsovszki
Principal Investigator Email
csacsotto@gmail.com
Contact Person Name
Otto Csacsovszki
Contact Person Email
csacsotto@gmail.com
Site Name
Semmelweis University
Department Name
hematology and internal medicine department
Principal Investigator Name
Nagy Zsolt
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Nagy Zsolt

Spain

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
07-06-2024
Processing Time Days
107
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Hospital San Pedro de Alcantara
Department Name
Hematology
Principal Investigator Name
Juan Miguel Bergua Burgues
Principal Investigator Email
jmberguaburg@gmail.com
Contact Person Name
Juan Miguel Bergua Burgues
Contact Person Email
jmberguaburg@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Hematology
Principal Investigator Name
Pilar Gomez Prieto
Principal Investigator Email
pilar.gph@gmail.com
Contact Person Name
Pilar Gomez Prieto
Contact Person Email
pilar.gph@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Clinical Hematology
Principal Investigator Name
Eva Maria Gonzalez Barca
Principal Investigator Email
e.gonzalez@iconcologia.net
Contact Person Name
Eva Maria Gonzalez Barca
Contact Person Email
e.gonzalez@iconcologia.net
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Fatima De La Cruz Vicente
Principal Investigator Email
fatimadelacruzv@gmail.com
Contact Person Name
Fatima De La Cruz Vicente
Contact Person Email
fatimadelacruzv@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Javier Lopez Jimenez
Principal Investigator Email
jljimenez@salud.madrid.org
Contact Person Name
Javier Lopez Jimenez
Contact Person Email
jljimenez@salud.madrid.org
Site Name
Hospital Del Mar
Department Name
Clinical Hematology
Principal Investigator Name
Blanca Sanchez
Principal Investigator Email
97894@hospitaldelmar.cat
Contact Person Name
Blanca Sanchez
Contact Person Email
97894@hospitaldelmar.cat
Site Name
Hospital Arnau De Vilanova De Valencia
Department Name
Hematology
Principal Investigator Name
Francisca Lopez Chulia
Principal Investigator Email
lopez_frachu@gva.es
Contact Person Name
Francisca Lopez Chulia
Contact Person Email
lopez_frachu@gva.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
Raul Cordoba Mascuñano
Principal Investigator Email
raul.cordoba@fjd.es
Contact Person Name
Raul Cordoba Mascuñano
Contact Person Email
raul.cordoba@fjd.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology
Principal Investigator Name
Sonia Gonzalez de Villambrosia
Principal Investigator Email
sonia.glezdevillambrosi@scsalud.es
Contact Person Name
Sonia Gonzalez de Villambrosia

Czechia

Earliest CTIS Part Ii Submission Date
21-02-2024
Latest Decision Or Authorization Date
12-03-2024
Processing Time Days
20
Number Of Sites
3
Number Of Participants
23

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Clinic of Internal Haematology
Principal Investigator Name
Heidi Móciková
Principal Investigator Email
heidi.mocikova@fnkv.cz
Contact Person Name
Heidi Móciková
Contact Person Email
heidi.mocikova@fnkv.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
Clinic of haematooncology
Principal Investigator Name
Juraj Ďuraš
Principal Investigator Email
juraj.duras@fno.cz
Contact Person Name
Juraj Ďuraš
Contact Person Email
juraj.duras@fno.cz
Site Name
Fakultni Nemocnice V Motole
Department Name
Oncology Clinic of the 2nd Faculty of Medicine, Charles University, and Motol University Hospital
Principal Investigator Name
Kateřina Kopečková
Principal Investigator Email
katerina.kopeckova@fnmotol.cz
Contact Person Name
Kateřina Kopečková
Contact Person Email
katerina.kopeckova@fnmotol.cz

Sponsor

Primary sponsor

Full Name
ADC Therapeutics S.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple sponsor duties including Medial Writing Support (codes present in sponsorDuties array)
Name
PPD International Holdings LLC
Responsibilities
Logistics, sample storage
Name
Pharmaceutical Product Development LLC
Responsibilities
Logistics, sample storage
Name
Iqvia Rds Inc.
Responsibilities
Data services / other (code 8 indicated)

Third parties

  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1,12,13,15 (Medial Writing Support),2,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"IVRS - treatment randomisation","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Logistics, sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"DNA samples; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.; Primary/ surrogate endpoint test","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Patient Reported Outcomes(ePRO)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Logistics, sample storage","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Histopathology, Tumor Tissue; code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Netherlands","full_name":"Pharmaceutical Research Associates Group B.V.","duties_or_roles":"PK and ADA sample analysis, sample storage during study","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment Rental","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6,7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
Zynlonta 10 mg powder for concentrate for solution for infusion
Active Substance
loncastuximab tesirine
Modality
ADC
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Authorised (EU marketing authorisation EU/1/22/1695/001)
Starting Dose
150 µg/Kg
Maximum Dose
750 µg/Kg
Investigational Product Name
Truxima 100 mg concentrate for solution for infusion
Active Substance
rituximab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Authorised (EU/1/16/1167/002)
Starting Dose
375 mg/m2
Maximum Dose
3000 mg/m2
Investigational Product Name
OXALIPLATIN
Active Substance
oxaliplatin
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Not authorised (no marketing authorisation number listed)
Starting Dose
100 mg/m2
Maximum Dose
800 mg/m2
Investigational Product Name
GEMCITABINE
Active Substance
gemcitabine
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
INTRAVENOUS
Authorisation Status
Not authorised (no marketing authorisation number listed)
Starting Dose
1000 mg/m2
Maximum Dose
8000 mg/m2
Investigational Product Name
Dexamethason 4 mg GALEN®
Active Substance
dexamethasone
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
Authorised (marketing authorisation number 33652.00.00 in DE)
Starting Dose
4 mg
Maximum Dose
96 mg
Combination Treatment
Yes

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