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Clinical trials for Bosutinib

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    32 result(s) found for: Bosutinib. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2013-000691-15 Sponsor Protocol Number: B1871040 Start Date*: 2013-07-08
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
    Medical condition: Chronic Myeloid Leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) HU (Completed) LT (Prematurely Ended) LV (Completed) NL (Completed) FI (Completed) ES (Completed) GB (Completed) FR (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002782-34 Sponsor Protocol Number: B1871061 Start Date*: 2020-09-03
    Sponsor Name:Pfizer Inc.
    Full Title: A phase 1, open-label, randomized, 2-period, 2 sequence, crossover study to evaluate the bioequivalence of Bosutinib pediatric capsule and the commercial tablet formulations in healthy participants...
    Medical condition: Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004864 10082178 Philadelphia positive chronic myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002916-34 Sponsor Protocol Number: ITCC-054/AAML1921 Start Date*: 2016-06-13
    Sponsor Name:Erasmus MC
    Full Title: A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia, study ITCC-054/COG AAML1921
    Medical condition: Chronic Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009700 CML LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IE (Completed) DE (Ongoing) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned) DK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004323-37 Sponsor Protocol Number: BOS-IIG-01 Start Date*: 2015-03-24
    Sponsor Name:Fundación PETHEMA para el tratamiento de la leucemia y el linfoma
    Full Title: Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment.
    Medical condition: Patients with chromosome Philadelphia positive (Ph+) in chronic phase mielogenus leukemia (CP CML)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10034877 Philadelphia chromosome positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005101-31 Sponsor Protocol Number: AV001 Start Date*: 2014-06-17
    Sponsor Name:Pfizer Inc
    Full Title: A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
    Medical condition: Chronic Myeloid Leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) IT (Completed) SE (Completed) CZ (Completed) HU (Completed) SK (Completed) FI (Completed) NO (Completed) ES (Completed) DK (Completed) NL (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-005531-13 Sponsor Protocol Number: MED3-201401 Start Date*: 2015-11-26
    Sponsor Name:Univerity of Bonn
    Full Title: Multicenter, open-label single arm phase II study testing the tolerability and the efficacy of Bosutinib step-in dosing in Chronic Phase CML patients intolerant or refractory to previous Imatinib, ...
    Medical condition: Chronic Phase Chronic myelogenous leukaemia( CP-CML) patients who either developed intolerance or treatment failure to previous Imatinib, Dasatinib or Nilotinib as 1st or 2nd line therapy.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-003780-50 Sponsor Protocol Number: B1871008 Start Date*: 2008-07-30
    Sponsor Name:Wyeth Pharmaceuticals Inc, a wholly owned subsidiary of Pfizer Inc, 500 Arcola Road, Collegeville, PA 19426 USA
    Full Title: A Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
    Medical condition: Chronic myelogenous leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) GB (Completed) BE (Completed) ES (Completed) LV (Completed) LT (Completed) FR (Completed) IT (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2008-002457-20 Sponsor Protocol Number: 3160A6-2206 Start Date*: 2008-12-30
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: "Estudio de fase 2, aleatorizado y abierto, de bosutinib administrado en combinación con exemestano frente a exemestano solo como tratamiento de segunda línea en mujeres posmenopáusicas con cáncer ...
    Medical condition: Cáncer de mama localmente avanzado o metastásico, RE+/RPg+/erbB2- en mujeres posmenopáusicas. Locally advanced or metastatic ER+/PgR+/Her2-breast cancer in post-menopausal women
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) BE (Completed) NL (Completed) FR (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023017-65 Sponsor Protocol Number: B1871019 Start Date*: 2011-03-17
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, CLINICAL ACTIVITY AND PHARMACOKINETICS OF BOSUTINIB (PF-05208763) VERSUS PLACEBO IN SUBJECTS WITH AUTOSOMAL...
    Medical condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10036046 Polycystic kidney, autosomal dominant LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) CZ (Completed) HU (Completed) GB (Completed) PL (Completed) SK (Completed) LT (Completed) IT (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002461-66 Sponsor Protocol Number: CABL001A2301 Start Date*: 2017-10-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyro...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Ongoing) BG (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) NL (Completed) BE (Completed) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-011878-15 Sponsor Protocol Number: 3160A6-2208-WW Start Date*: 2009-08-14
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc
    Full Title: A phase 1/2, open-label study of bosutinib administered in combination with capecitabine in subjects with solid tumor and ErbB2 negative locally advanced or metastatic breast cancer.
    Medical condition: Solid tumor and ErbB2 negative locally advanced or metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    12.0 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) BE (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-000678-27 Sponsor Protocol Number: CABL001J12301 Start Date*: 2021-08-10
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leuk...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP) in newly diagnosed patients
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) SK (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) BG (Trial now transitioned) FI (Trial now transitioned) NL (Completed) DK (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-006252-21 Sponsor Protocol Number: 3160A6-2207-WW Start Date*: 2009-05-28
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc
    Full Title: A Phase 2, Randomized, Open-label Study of Bosutinib Administered in Combination With Letrozole Versus Letrozole Alone as First Line Therapy in Post-Menopausal Women With Locally Advanced or Metast...
    Medical condition: Locally advanced or metastatic ER+/PgR+/erbB2-breast cancer in post-menopausal women
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Completed) BE (Completed) GB (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003250-25 Sponsor Protocol Number: B1871039 Start Date*: 2014-06-24
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: A Phase 4 Safety and Efficacy Study of Bosutinib (Bosulif®) in Patients with Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated with One or More Tyrosine Kinase Inhibitors
    Medical condition: Philadelphia Chromosome Positive Chronic Myeloid Leukaemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) DE (Prematurely Ended) IT (Completed) BE (Completed) NL (Completed) ES (Completed) AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2005-004230-40 Sponsor Protocol Number: B1871006 Start Date*: 2006-02-17
    Sponsor Name:Wyeth Pharmaceuticals Inc., a wholly owned subsidary of Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA
    Full Title: A Phase 1/2 Study of SKI-606 in Philadelphia Chromosme Positive Leukemias
    Medical condition: Philadelphia Chromosome positive leukemias occur as a result of a reciprocal translocation between chromosomes 9 and 22. Its most common phenotype is Chronic Myelogenous Leukemia (CML), which has ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004848 10034877 Philadelphia chromosome positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HU (Completed) AT (Completed) FI (Completed) SE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002216-40 Sponsor Protocol Number: CML1516 Start Date*: 2016-10-04
    Sponsor Name:FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS
    Full Title: BOSUTINIB EFFICACY SAFETY TOLERABILITY (BEST) STUDY IN ELDERLY CHRONIC MYELOID LEUKEMIA PATIENTS FAILING FRONT-LINE TREATMENT WITH OTHER TYROSINE KINASE INHIBITORS
    Medical condition: Chronic Myeloid Leukemia (CML) in Chronic Phase
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001334-18 Sponsor Protocol Number: CarPAs Start Date*: 2020-09-10
    Sponsor Name:Associazione Italiana Pazienti Leucemia Mieloide Cronica (AIPLMC)
    Full Title: Cardiovascular assessment of Ponatinib as treatment option in chronic phase chronic myeloid leukemia after failure of Imatinib and Bosutinib (CarPAs)
    Medical condition: Chronic Myeloid Leukemia (CML) in Chronic Phase (CP)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-001843-29 Sponsor Protocol Number: TASTER2018 Start Date*: 2019-05-28
    Sponsor Name:NHS Greater Glasgow and Clyde [...]
    1. NHS Greater Glasgow and Clyde
    2. University of Glasgow
    Full Title: TASTER- TArgeting STEm cell Resistance An umbrella adaptive randomised multi–arm screening phase II trial for patients with 2nd/3rd generation TKI resistant chronic myeloid leukaemia
    Medical condition: Chronic myeloid leukaemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009013 Chronic myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2022-004165-20 Sponsor Protocol Number: AITIK Start Date*: 2023-04-26
    Sponsor Name:CHU de Poitiers
    Full Title: Discontinuation of Tyrosine Kinase Inhibitors in chronic myeloid leukemia and impact on the immune system: a randomized controlled trial of two therapeutic strategies
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10009015 Chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001044-54 Sponsor Protocol Number: Bosupeg Start Date*: 2018-10-04
    Sponsor Name:St Olavs Hospital -Trondheim University Hospital
    Full Title: A STUDY OF EFFICACY AND SAFETY OF LONG-ACTING LOW DOSE ROPEGINTERFERON IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA TREATED WITH BOSUTINIB FROM DIAGNOSIS: A RANDOMIZED PROSPECTIVE TRIAL
    Medical condition: Chronic myeloid leukemia at diagnosis-chronich phase
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
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