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Clinical trials for Sonidegib

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    10 result(s) found for: Sonidegib. Displaying page 1 of 1.
    EudraCT Number: 2012-004113-13 Sponsor Protocol Number: CLDE225XBE01T Start Date*: 2012-11-05
    Sponsor Name:GZA vzw, GZA Ziekenhuizen, Sint-Augustinus
    Full Title: A Phase II, Open-Label, Safety, Efficacy and Pharmacodynamic Study of oral sonidegib in patients with Basal Cell Carcinoma (BCC) and prior exposure to Hedgehog Pathway inhibitors
    Medical condition: Basal Cell Carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002613-17 Sponsor Protocol Number: SONIBEC Start Date*: 2020-10-13
    Sponsor Name:G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
    Full Title: A phase II, open-label study improving compliance and time of treatment after obtaining complete response through a tailored schedule of sonidegib in locally advanced basal cell carcinomas (BCC) – ...
    Medical condition: Adult patients with locally advanced BCC, not amenable to surgical treatment and who obtained a complete response (CR) to Hedgehog inhibitors as defined by RECIST 1.1 and dermoscopic exam regardles...
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10064679 Basal cell carcinoma of skin in situ LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-001309-22 Sponsor Protocol Number: 2593957 Start Date*: 2021-03-29
    Sponsor Name:IQVIA Commercial GmbH & Co. OHG
    Full Title: Evaluation of immunological effects of the hedgehog inhibitors on basal cell carcinoma - An open label, prospective, observational biomarker study of the DeCOG.
    Medical condition: Basal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10064679 Basal cell carcinoma of skin in situ LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003063-26 Sponsor Protocol Number: 1634 Start Date*: 2023-08-10
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: Personalized Risk-Adapted Therapy in Post-Pubertal Patients with Newly Diagnosed Medulloblastoma (PersoMed-I)
    Medical condition: Newly Diagnosed Medulloblastoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) DE (Trial now transitioned) IT (Prematurely Ended) FR (Prematurely Ended) NL (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-004023-20 Sponsor Protocol Number: CLDE225X2116 Start Date*: 2013-06-21
    Sponsor Name:Novartis Farmacéutica S.A.
    Full Title: A Phase Ib/II, open-label, multi-center, dose-finding study to assess the safety and efficacy of the oral combination of LDE225 and INC424 (Ruxolitinib) in patients with myelofibrosis
    Medical condition: myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Prematurely Ended) IE (Prematurely Ended) IT (Completed) DE (Completed) NL (Prematurely Ended) FR (Prematurely Ended) DK (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-004022-21 Sponsor Protocol Number: CLDE225X2203 Start Date*: 2013-05-08
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase II multi-center, open label, randomized study to assess safety and efficacy of two different schedules of oral LDE225 in adult patients with relapsed/refractory or untreated elderly patient...
    Medical condition: relapsed/refractory or untreated acute leukemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10000835 Acute leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) ES (Completed) GB (Prematurely Ended) IE (Prematurely Ended) SE (Prematurely Ended) NO (Completed) BE (Completed) DE (Completed) FR (Completed) NL (Completed) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002370-51 Sponsor Protocol Number: 2013-002370-51 Start Date*: 2013-12-03
    Sponsor Name:Academic Medical Center
    Full Title: Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with locally advanced or metastasized pancreatic cancer
    Medical condition: Pancreatic cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022629-14 Sponsor Protocol Number: CLDE225A2201 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase II, randomized double-blind study of efficacy and safety of two dose levels of LDE225 in patients with locally advanced or metastatic basal cell carcinoma
    Medical condition: locally advanced or metastatic basal cell carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10066495 Basal cell carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GR (Prematurely Ended) GB (Prematurely Ended) ES (Completed) NL (Prematurely Ended) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003066-40 Sponsor Protocol Number: CLDE225C2301 Start Date*: 2013-02-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase II, multi-center, open-label, single-arm study of the efficacy and safety of oral LDE225 versus temozolomide in patients with Hh-pathway activated relapsed medulloblastoma
    Medical condition: Relapsed medulloblastoma characterised by Hedgehog (Hh)-pathway activation
    Disease: Version SOC Term Classification Code Term Level
    19.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066594 Medulloblastoma recurrent PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) IT (Completed) ES (Completed) DE (Completed) GB (Completed) FR (Completed) NL (Completed) BE (Completed) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004274-15 Sponsor Protocol Number: Pelle-926-201 Start Date*: 2016-02-22
    Sponsor Name:PellePharm, Inc.
    Full Title: Double-Blind, Randomized, Vehicle-Controlled Proof of Concept Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndr...
    Medical condition: Basal Cell Nevus Syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10004151 Basal cell nevus syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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    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.

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