Clinical trial • Phase III • Oncology|Rare Disease

ASCIMINIB HYDROCHLORIDE for Chronic myeloid leukemia

Phase III trial of ASCIMINIB HYDROCHLORIDE for Chronic myeloid leukemia.

Overview

Trial Therapeutic Area
Oncology|Rare Disease
Trial Disease
Chronic myeloid leukemia
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
01-03-2024
First CTIS Authorization Date
13-05-2024

Trial design

Randomised, open-label, investigator-selected tyrosine kinase inhibitor (tki) comparator arm: imatinib (reference/formulations listed; max daily dose 400 mg), nilotinib (max daily dose 600 mg), dasatinib (max daily dose 100 mg), bosutinib (max daily dose 400 mg); investigator selects tki pre-randomization.-controlled Phase III trial in Hungary, Finland, Denmark and others.

Randomised
Yes
Open Label
Yes
Comparator
Investigator-selected tyrosine kinase inhibitor (TKI) comparator arm: Imatinib (reference/formulations listed; max daily dose 400 mg), Nilotinib (max daily dose 600 mg), Dasatinib (max daily dose 100 mg), Bosutinib (max daily dose 400 mg); investigator selects TKI pre-randomization.
Target Sample Size
246
Trial Duration For Participant
672

Stratification factors

  • Pre-randomization selected TKI (imatinib vs other)

Eligibility

Recruits 246 No vulnerable populations selected; participants are adults (≥18). Signed informed consent must be obtained from each participant prior to any study-related screening procedures. (Country-specific ICFs and follow-up forms exist; assent is not applicable as only adults are eligible.).

Vulnerable Population
No vulnerable populations selected; participants are adults (≥18). Signed informed consent must be obtained from each participant prior to any study-related screening procedures. (Country-specific ICFs and follow-up forms exist; assent is not applicable as only adults are eligible.)

Inclusion criteria

  • {"criterion_text":"- Male or female participants ≥ 18 years of age."}
  • {"criterion_text":"- Participants with CML-CP within 3 months of diagnosis."}
  • {"criterion_text":"- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome •\tDocumented chronic phase CML will meet all the below criteria (Hochhaus et al 2020): •\t< 15% blasts in peripheral blood and bone marrow, •\t< 30% blasts plus promyelocytes in peripheral blood and bone marrow, •\t< 20% basophils in the peripheral blood, •\tPlatelet (PLT) count ≥ 100 x 109/L (≥ 100,000/mm3), •\tNo evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly."}
  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1."}
  • {"criterion_text":"- Adequate end organ function as defined by: •\tTotal bilirubin (TBL) < 3 x upper limit of normal (ULN); participants with Gilbert’s syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN •\tCreatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula •\tSerum 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"}
  • {"criterion_text":"- Participants must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization: •\tPotassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min) •\tTotal calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min) •\tMagnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min) •\tFor participants with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization. •\tCrCl* as calculated using Cockcroft-Gault formula"}
  • {"criterion_text":"- Signed informed consent must be obtained prior to any study related screening procedures being performed."}
  • {"criterion_text":"- Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification."}

Exclusion criteria

  • {"criterion_text":"- Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤ 2 weeks is allowed. No treatment with other tyrosine kinase inhibitors prior to randomization is permitted."}
  • {"criterion_text":"- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required)."}
  • {"criterion_text":"- Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: •\tHistory within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG). •\tClinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block). •\tQTc ≥ 450 ms (male participants), ≥ 460 ms (female participants) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the participant re-screened for QTc. •\tLong QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: •\tRisk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. •\tConcomitant medication(s) with a “Known risk of Torsades of Pointes” per //.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication. •\tInability to determine the QTcF interval."}
  • {"criterion_text":"- Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g., uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia)."}
  • {"criterion_text":"- History of significant congenital or acquired bleeding disorder unrelated to cancer."}
  • {"criterion_text":"- Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery."}
  • {"criterion_text":"- History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively."}
  • {"criterion_text":"- History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis."}
  • {"criterion_text":"- History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Major Molecular Response (MMR) at Week 48 (Yes/No)","definition_or_measurement_approach":"Proportion of participants in Major Molecular Response at Week 48 measured by standardized real-time quantitative PCR (RQ-PCR) for BCR-ABL1 transcripts (e14a2 and/or e13a2)."}

Secondary endpoints

  • {"endpoint_text":"- Major Molecular Response (MMR) at Week 96 (Yes/No)","definition_or_measurement_approach":"Proportion of participants in Major Molecular Response at Week 96 measured by standardized real-time quantitative PCR (RQ-PCR) for BCR-ABL1 transcripts (e14a2 and/or e13a2)."}
  • {"endpoint_text":"- Major Molecular response (MMR) at Week 96 (Yes/No)","definition_or_measurement_approach":"Proportion of participants in Major Molecular Response at Week 96 measured by standardized real-time quantitative PCR (RQ-PCR) for BCR-ABL1 transcripts (e14a2 and/or e13a2)."}

Recruitment

Planned Sample Size
246
Recruitment Window Months
111
Consent Approach
Signed informed consent must be obtained from each participant prior to any study-related screening procedures. Participants are adults (≥18). Country-specific informed consent forms are provided (multiple language versions are available across participating countries, e.g., Hungarian, Finnish, Danish, Czech, Portuguese, Spanish, Italian, German, Swedish, Bulgarian, English, Dutch, Norwegian, French) and follow-up ICFs (including pregnancy follow-up forms) are provided as applicable.

Geography

Total Number Of Sites
41
Total Number Of Participants
159

Hungary

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
598
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
#2002: Hematológiai Osztály
Contact Person Name
Miklos Egyed
Contact Person Email
dregyedmiklos@yahoo.com
Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
#2001: II. Belgyogyaszati Osztaly
Contact Person Name
Mihaly Gurzo
Contact Person Email
gurzom@kmk.hu
Site Name
University Of Debrecen
Department Name
#2000: Hematologia Osztaly
Contact Person Name
Arpad Illes
Contact Person Email
illesarpaddr@gmail.com

Finland

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
15-05-2024
Processing Time Days
54
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
HUS-Yhtymae
Department Name
#2061: HUS Syöpäkeskus Hematologian linja
Contact Person Name
Perttu Koskenvesa
Contact Person Email
perttu.koskenvesa@hus.fi

Denmark

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
595
Number Of Sites
2
Number Of Participants
3

Sites

Site Name
Aarhus Universitetshospital
Department Name
#2070: Blodsygdomme
Contact Person Name
Peter Buur van Kooten Niekerk
Contact Person Email
petevank@rm.dk
Site Name
Rigshospitalet
Department Name
#2071: Afdeling for Blodsygdomme, Klinsk forskningsenhed
Contact Person Name
Mette Borg Clausen
Contact Person Email
Mette.borg.clausen@regionh.dk

Czechia

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
598
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
#2080: Interni hematologicka a onkologicka klinika
Contact Person Name
Jiri Mayer
Contact Person Email
mayer.jiri@fnbrno.cz
Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
#2081: IV. interni hematologicka klinika
Contact Person Name
Petra Belohlavkova
Contact Person Email
petra.belohlavkova@fnhk.cz
Site Name
Fakultni Nemocnice Ostrava
Department Name
#2082: Klinika hematoonkologie
Contact Person Name
Lukas Stejskal
Contact Person Email
lukas.stejskal@fno.cz

Portugal

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
599
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
#2142: Serviço de Hematologia
Contact Person Name
Isabel Oliveira
Site Name
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Department Name
#2140: Serviço de Hematologia
Contact Person Name
Teresa Melo

Spain

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
600
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
#2043: Consulta Hematología
Contact Person Name
José Manuel Puerta Puerta
Site Name
Hospital Clinic De Barcelona
Department Name
#2041: Inther unit
Contact Person Name
Alberto Alvarez Larran
Contact Person Email
aalvar@clinic.cat
Site Name
Hospital Universitario De Navarra
Department Name
#2040: ensayos clínicos
Contact Person Name
Maria Angeles Goñi Herranz
Contact Person Email
agoniher@cfnavarra.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
#2042: Unidad de trasplante hematopoyético y terapia celular
Contact Person Name
Raúl Pérez López
Contact Person Email
raul.perez@carm.es
Site Name
Hospital Universitario La Paz
Department Name
#2044: Servicio Hematología
Contact Person Name
Raquel de Paz Arias
Contact Person Email
rpaz.hulp@salud.madrid.org

Italy

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
599
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
#2160: UOC Ematologia, Ospedale Borgo Roma Policlinico G. B. Rossi
Contact Person Name
Massimiliano Bonifacio
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
#2161: Istituto di Ematologia L.e A.Seragnoli
Contact Person Name
Fausto Castagnetti
Contact Person Email
fausto.castagnetti@unibo.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
#2162: UOC Ematologia, Università La Sapienza
Contact Person Name
Massimo Breccia
Contact Person Email
massimo.breccia@uniroma1.it
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
#2164: UOC Ematologia, Presidio Ospedaliero Arcispedale S. Maria Nuova
Contact Person Name
Isabella Capodanno
Contact Person Email
isabella.capodanno@asmn.re.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
#2163: SC Ematologia
Contact Person Name
Alessandra Iurlo

Germany

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
595
Number Of Sites
6
Number Of Participants
35

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#2154: Hämatologie und Onkologie und Tumorimmunologie
Contact Person Name
Philipp David Immanuel Le Coutre
Contact Person Email
Philipp.lecoutre@charite.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
#2150: Hämatologie und Internistische Onkologie
Contact Person Name
Andreas Hochhaus
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
#2151: III. Medizinische Klinik – Hämatologie und Internistische Onkologie
Contact Person Name
Susanne Saußele
Site Name
Goethe University Frankfurt
Department Name
#2153: Hämatologie und Onkologie
Contact Person Name
Fabian Lang
Contact Person Email
Fabian.Lang@kgu.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
#2152: Hämatologie und Onkologie
Contact Person Name
Tim Brümmeldorf
Contact Person Email
tbruemmendorf@ukaachen.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#2155: Hämatologie und Onkologie
Contact Person Name
Nikolas Von Bubnoff
Contact Person Email
Nikolas.vonbubnoff@uksh.de

Austria

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
10-11-2025
Processing Time Days
598
Number Of Sites
1
Number Of Participants
1

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Main Centre
Contact Person Name
Gregor Aschauer

Slovakia

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
07-11-2025
Processing Time Days
595
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
#2112: Klinika Hematológie a Onkohematológie
Contact Person Name
Tomáš Guman
Contact Person Email
tomas.guman@unlp.sk

Belgium

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
18-12-2025
Processing Time Days
636
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
UZ Leuven
Department Name
#2030: Hematology
Contact Person Name
Peter Vandenberghe
Contact Person Email
peter.vandenberghe@uzleuven.be
Site Name
Institut Jules Bordet
Department Name
#2033: Hematology
Contact Person Name
Adriano Salaroli
Contact Person Email
adriano.salaroli@bordet.be

Norway

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
08-01-2026
Processing Time Days
657
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Oslo University Hospital HF
Department Name
#2050: Avdeling for blodsykdommer
Contact Person Name
Tobias Gedde-Dahl
Contact Person Email
tgeddeda@ous-hf.no
Site Name
Helse Bergen HF
Department Name
#2051: Seksjon for blodsjukdommar
Contact Person Name
Bjørn Tore Gjertsen

Bulgaria

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
671
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
University Hospital St Marina Varna
Department Name
#2091: Clinic of Clinical Hematology
Contact Person Name
Ilina Micheva
Contact Person Email
ilinamicheva@gmail.com

France

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
18-03-2026
Processing Time Days
726
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#2014: Hematologie clinique
Contact Person Name
Viviane DUBRUILLE
Site Name
Centre Leon Berard
Department Name
#2012: Hematologie
Contact Person Name
Franck NICOLINI
Site Name
Hopital Saint Louis
Department Name
#2010: Hematologie et Immunologie
Contact Person Name
Delphine REA
Contact Person Email
delphine.rea@aphp.fr
Site Name
Institut Bergonie
Department Name
#2011: Oncologie medicale
Contact Person Name
Gabriel ETIENNE

Sweden

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
759
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
#2101: Hematologimottagningen
Contact Person Name
Anna Lübking
Contact Person Email
anna.lubking@skane.se
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
#2102: Sektionen för hematologi och koagulation
Contact Person Name
Lovisa Wennström
Contact Person Email
lovisa.vennstrom@vgregion.se
Site Name
Karolinska University Hospital
Department Name
#2103: Cancerstudieenheten, M62
Contact Person Name
Stefan Deneberg

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Parexel International (IRL) Limited
Responsibilities
code 12
Name
Syneos Health Inc.
Responsibilities
code 1
Name
IQVIA Limited
Responsibilities
code 1; ECG analysis / review; code 3
Name
Icon Clinical Research Limited
Responsibilities
code 1; code 4
Name
Navigate Biopharma Services Inc.
Responsibilities
Biomarker analysis (whole blood for cellular markers analysis); code 4
Name
Veeda Clinical Research Limited
Responsibilities
Pharmacokinetic analysis; code 15; code 4
Name
Clinical Outcomes Solutions LLC
Responsibilities
code 10

Third parties

  • {"country":"United States","full_name":"Clinical Outcomes Solutions LLC","duties_or_roles":"code 10","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"Local drug supply and labelling","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Specific Pharma A/S","duties_or_roles":"code 14; Country depot services, drug distribution, return and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"TMF archive","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code 12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q Squared Solutions LLC","duties_or_roles":"Central lab; code 15; code 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code 1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 6; code 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"code 14; Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"code 13","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Austria","full_name":"Mag. Andreas Raffeiner GmbH","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
  • {"country":"Australia","full_name":"Sa Pathology","duties_or_roles":"Biomarker Analysis; code 15; code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Denmark","full_name":"Eurofins Genomics Europe AgriGenomics Products & Services A/S","duties_or_roles":"Pharmacogenomics; code 15; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"Pharmacokinetic analysis; code 15; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"code 1; ECG analysis / review; code 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"Biomarker analysis (whole blood for cellular markers analysis); code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code 1; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Wuxi Apptec Co. Ltd.","duties_or_roles":"Pharmacokinetic analysis; code 15; code 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Patients Reported Outcomes Assessments (ePRO) and Trial Feedback Questionnaire (TFQ); code 15; code 7","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
ASCIMINIB HYDROCHLORIDE
Active Substance
ASCIMINIB HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Orphan Designation
Yes
Maximum Dose
80 mg (maxDailyDoseAmount)
Investigational Product Name
IMATINIB
Active Substance
IMATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
400 mg (maxDailyDoseAmount)
Investigational Product Name
NILOTINIB
Active Substance
NILOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
600 mg (maxDailyDoseAmount)
Investigational Product Name
DASATINIB
Active Substance
DASATINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
100 mg (maxDailyDoseAmount)
Investigational Product Name
BOSUTINIB
Active Substance
BOSUTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Authorisation Status
prodAuthStatus 2
Maximum Dose
400 mg (maxDailyDoseAmount)

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