Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Nilotinib

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    89 result(s) found for: Nilotinib. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2010-023508-28 Sponsor Protocol Number: CAMN107GB05T Start Date*: 2011-04-14
    Sponsor Name:Plymouth Hospital NHS Trust
    Full Title: A CLINICAL TRIAL OF THE INTRA-TUMOURAL CONCENTRATION AND ACTIVITY OF NILOTINIB IN INTRA-CUTANEOUS SCHWANNOMAS
    Medical condition: In vivo investigation of the intra-tumoural concentration and activity of nilotinib in cutaneous schwannomas (CS) in patienst with Neurofibromatosis 2
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004048-31 Sponsor Protocol Number: CHUBX2012/18 Start Date*: 2014-04-07
    Sponsor Name:CHU de Bordeaux
    Full Title: Multicenter single-arm pilot study evaluating efficacy of nilotinib in CML patients with molecular relapse after Glivec discontinuation within the context of the STIM trials (STIM and STIM2), Nilo ...
    Medical condition: Chronic myeloid leukemia (CML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005124-15 Sponsor Protocol Number: CAMN107AIC05 Start Date*: 2013-02-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia chromosome-positive CML after two different durations of ...
    Medical condition: Adult patients with Ph+ chronic phase CML that have been treated with Imatinib for at least 2 years, are in CCyR, but have not achieved MR4.0 at study entry.
    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: AT (Completed) SK (Completed) SE (Completed) HU (Completed) IT (Completed) DE (Completed) NO (Completed) PT (Completed) FI (Completed) ES (Completed) IE (Completed) CZ (Completed) BG (Completed) BE (Completed) GR (Completed) DK (Completed) SI (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004092-40 Sponsor Protocol Number: CAMN107I2201 Start Date*: 2013-03-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A single-arm, multicenter, nilotinib treatment-free remission study in patients with BCR-ABL1 positive Chronic Myelogenous Leukemia in chronic phase who have achieved durable minimal residual disea...
    Medical condition: Adult patients treated with a planned dose of nilotinib 300 mg BID (or at a reduced dose level of 400 mg QD if required from the perspective of tolerance) for a minimum of 2 calendar years for newl...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) IT (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) IE (Completed) PL (Completed) DK (Completed) NL (Ongoing) GR (Completed) HU (Completed) FR (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-004467-19 Sponsor Protocol Number: CAMN107AHU01 Start Date*: 2008-08-13
    Sponsor Name:Novartis Hungary Ltd
    Full Title: An open-label, single center study of oral AMN 107 (nilotinib) in adult patients with imatinib - resistant or - intolerant chronic myeloid leukemia in chronic phase, accelerated phase or blast cri...
    Medical condition: adult patients with imatinib - resistant or - intolerant CML-CP, CML-AP or CML-BC
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003186-18 Sponsor Protocol Number: CAMN107A2408 Start Date*: 2013-02-19
    Sponsor Name:Novartis Farmacéutica S.A.
    Full Title: A phase II, single arm, open label study of treatment-free remission after achieving sustained MR4.5 on nilotinib
    Medical condition: Ph+ chronic myeloid leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed) BE (Completed) GR (Completed) GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-000208-34 Sponsor Protocol Number: CAMN107A2303 Start Date*: 2007-06-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III multi-center, open label, randomised study of imatinib versus nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chr...
    Medical condition: Adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009015 Chronic myeloid leukemia LLT
    20.1 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) CZ (Completed) BE (Completed) IT (Completed) ES (Completed) SK (Completed) AT (Completed) FR (Completed) NL (Completed) FI (Completed) DK (Completed) DE (Completed) PT (Prematurely Ended) HU (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-005047-26 Sponsor Protocol Number: CAMN107A2302 Start Date*: 2007-10-15
    Sponsor Name:Novartis Pharma Services
    Full Title: A phase III multi-center, open-label, randomized study of the efficacy of nilotinib versus imatinib in adult patients with Philadelphia chromosome positive (Ph+ ) chronic myelogenous leukemia in ...
    Medical condition: Nilotinib will be evaluated in patients having showed a suboptimal cytogenetic response to imatinib
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Prematurely Ended) ES (Completed) DE (Completed) IT (Prematurely Ended) NL (Prematurely Ended) HU (Prematurely Ended) FR (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2008-004758-34 Sponsor Protocol Number: CAMN107G2301 Start Date*: 2009-03-13
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tu...
    Medical condition: adult patients with histologically confirmed unresectable or metastatic GIST, either who have not received any prior anti-neoplastic therapy or, who experienced recurrence of GIST > 6 months after ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10062427 Gastrointestinal stromal tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Completed) SK (Completed) CZ (Completed) SE (Completed) HU (Completed) NL (Completed) DE (Completed) FR (Completed) IT (Completed) GB (Completed) DK (Prematurely Ended) GR (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-003902-28 Sponsor Protocol Number: CAMN107A2409 Start Date*: 2013-03-05
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open label, multi-center nilotinib roll-over protocol for patients who have completed a previous Novartis-sponsored nilotinib study and are judged by the investigator to benefit from continued ...
    Medical condition: Patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Global Development & Global Medical Affairs study and are benefiting from the treatment as judged by the investigator. All ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10062427 Gastrointestinal stromal tumor LLT
    20.0 100000004864 10001690 ALL LLT
    21.0 100000004864 10009700 CML LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed) ES (Ongoing) HU (Completed) NL (Completed) GB (GB - no longer in EU/EEA) SK (Completed) SE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2012-000770-36 Sponsor Protocol Number: 2009-18 Start Date*: 2013-05-14
    Sponsor Name:Centre Hospitalier Régional et Universitaire de Lille
    Full Title:
    Medical condition:
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000200-41 Sponsor Protocol Number: CAMN107A2203 Start Date*: 2013-07-22
    Sponsor Name:NOVARTIS FARMA S.p.A.
    Full Title: A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chro...
    Medical condition: newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib- bone marrow disea...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10054352 Chronic phase chronic myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) HU (Completed) BE (Completed) AT (Completed) GB (Completed) NL (Completed) DE (Ongoing) FR (Completed)
    Trial results: View results
    EudraCT Number: 2010-019883-36 Sponsor Protocol Number: CAMN107X2201 Start Date*: 2010-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH)
    Medical condition: Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064911 Pulmonary arterial hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) IT (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024262-22 Sponsor Protocol Number: CML-V Start Date*: 2012-08-24
    Sponsor Name:Friedrich-Schiller-Universität Jena
    Full Title: Treatment optimization of newly diagnosed Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib vs. nilotinib plus interferon alpha induction and nilotini...
    Medical condition: chronic phase CML
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10009700 CML LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017775-19 Sponsor Protocol Number: CAMN107EIC01 Start Date*: 2010-05-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase IIIb, multicentre, open-label study of nilotinib in adult patients with newly diagnosed Philadelphia chromosome and/or BCR-ABL positive CML in chronic phase
    Medical condition: Newly diagnosed Philadelphia chromosome and/or BCR-ABL positive chronic myeloid leukaemia (CML) in chronic phase in adult patients
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052065 Chronic phase chronic myeloid leukaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) BE (Completed) HU (Completed) ES (Completed) FI (Completed) GB (Completed) PT (Completed) DE (Completed) SE (Completed) CZ (Completed) DK (Completed) SK (Completed) GR (Completed) AT (Completed) LT (Completed) IT (Completed) LV (Completed) SI (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-002267-11 Sponsor Protocol Number: CAMN107A2201 Start Date*: 2006-11-10
    Sponsor Name:Novartis Pharma Services
    Full Title: A randomized, open-label,multi-center study to evaluate the efficacy of nilotinib versus imatinib in adult patients with gastrointestinal stromal tumors resistant to imatinib and resistant/intolera...
    Medical condition: Gastrointestinal stromal tumors (GIST)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) CZ (Completed) BE (Completed) FR (Completed) IT (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-015514-21 Sponsor Protocol Number: CAMN107B2301 Start Date*: 2010-04-16
    Sponsor Name:Novartis Pharma Services AG
    Full Title: The TEAM Trial (Tasigna Efficacy in Advanced Melanoma): A randomized, phase III, open label, multi-center, two-arm study to compare the efficacy of Tasigna ® versus dacarbazine (DTIC) in the treatm...
    Medical condition: treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation
    Disease: Version SOC Term Classification Code Term Level
    12.1 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) DE (Completed) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2010-023185-42 Sponsor Protocol Number: S105AMCNilotinibSpA Start Date*: 2011-04-21
    Sponsor Name:Academic Medical Center, Division of Clinical Immunology and Rheumatology
    Full Title: Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis
    Medical condition: Active axial and peripheral spondyloarthritis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001594-24 Sponsor Protocol Number: CABL001E2201 Start Date*: 2018-10-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase 2, multi-center, open-label, randomized study of oral asciminib added to imatinib versus continued imatinib versus switch to nilotinib in patients with CML-CP who have been previously treat...
    Medical condition: Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with imatinib and have not achieved deep molecular response
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) CZ (Trial now transitioned) ES (Ongoing) PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PL (Completed) DK (Completed) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018869-29 Sponsor Protocol Number: ET2009-095 Start Date*: 2010-07-29
    Sponsor Name:CENTRE LEON BERARD
    Full Title: Phase II study of nilotinib efficacy in Pigmented Villo-Nodular Synovitis / Tenosynovial Giant Cell Tumor (PVNS / TGCT)
    Medical condition: Patients with inoperable Pigmented Villonodular Synovitis / Tenosynovial Giant Cell Tumour (PVNS/TGCT)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10042875 Synovitis villonodular LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  Next»
    Query did not match any studies.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 28 23:19:34 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA