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Clinical trials for Gorlin syndrome

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   44335   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: Gorlin syndrome. Displaying page 1 of 1.
    EudraCT Number: 2018-001462-42 Sponsor Protocol Number: Pelle-926-301 Start Date*: 2019-01-22
    Sponsor Name:PellePharm, Inc.
    Full Title: A Multicenter, Randomized, Double blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cel...
    Medical condition: Basal Cell Nevus Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10004151 Basal cell nevus syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) ES (Ongoing) NL (Completed) DE (Completed) DK (Completed) BE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023819-34 Sponsor Protocol Number: CLDE225B2209 Start Date*: 2011-04-14
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase II, double-blind, randomized, Proof-of-Concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with Nevoid Basal Cell ...
    Medical condition: Nevoid Basal Cell carcinoma syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10004151 Basal cell nevus syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2020-000253-27 Sponsor Protocol Number: Pelle-926-301E Start Date*: 2020-06-05
    Sponsor Name:PellePharm, Inc.
    Full Title: A Phase 3, Multicenter, Open-Label Extension Study of Patidegib Topical Gel, 2% in Subjects with Gorlin Syndrome (Basal Cell Nevus Syndrome)
    Medical condition: Basal cell carcinomas (BCCs) in patients with Gorlin syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10004151 Basal cell nevus syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Prematurely Ended) NL (Prematurely Ended) DK (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) IT (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
    EudraCT Number: 2008-005506-40 Sponsor Protocol Number: CLDE225B2203 Start Date*: 2009-08-06
    Sponsor Name:Novartis Pharma
    Full Title: A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study, to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of...
    Medical condition: Gorlin syndrome
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-004945-27 Sponsor Protocol Number: SHH4476g Start Date*: 2009-07-09
    Sponsor Name:Genentech, Inc.
    Full Title: A PIVOTAL PHASE II, MULTICENTER, SINGLE ARM, TWO-COHORT TRIAL EVALUATING THE EFFICACY AND SAFETY OF GDC-0449 IN PATIENTS WITH ADVANCED BASAL CELL CARCINOMA
    Medical condition: • metastatic BCC with histologic confirmation of a distant BCC metastasis (e.g., lung, liver, lymph nodes, or bone) • locally advanced BCC considered inoperable or with medical contraindication to...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004338-13 Sponsor Protocol Number: 2013_36 Start Date*: 2014-12-08
    Sponsor Name:CHRU De Lille
    Full Title: Phase II study evaluating the interest of Vismodegib as neo-adjuvant treatment of basal cell carcinoma
    Medical condition: Male and female patients at least 18 years of age with histologically confirmed diagnoses of locally advanced BCC
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-004868-30 Sponsor Protocol Number: PNET5MB Start Date*: 2013-10-31
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (...
    Medical condition: Children with medulloblastoma. Medulloblastoma is a highly cellular malignant embryonal neoplasm.
    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: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Ongoing) NO (Completed) CZ (Trial now transitioned) NL (Trial now transitioned) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003305-10 Sponsor Protocol Number: MO28295 Start Date*: 2013-03-12
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A randomized, double-blinded, regimen controlled, phase II, multicenter study to assess the efficacy and safety of two different vismodegib regimens in patients with multiple basal cell carcinomas ...
    Medical condition: Adult patients with multiple basal cell carcinomas (BCCs).
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) NL (Completed) IT (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000195-34 Sponsor Protocol Number: MO25616 Start Date*: 2011-06-21
    Sponsor Name:F. Hoffmann-La Roche Ltd.
    Full Title: A single arm, open-label, phase II, multicentre study to assess the safety of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma (BCC).
    Medical condition: Locally advanced or metastatic basal cell carcinoma (BCC)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10004146 Basal cell carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) AT (Completed) DE (Completed) BG (Completed) GB (Completed) BE (Completed) IT (Completed) ES (Completed) NL (Completed) SI (Completed) DK (Completed) HU (Completed) CZ (Completed) GR (Completed) SK (Completed) IE (Completed) PT (Completed) PL (Completed) NO (Completed) LT (Completed) FI (Completed) EE (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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