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Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma (NISSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066504
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharmaceutical Industries Limited

Brief Summary:
Collect real world safety data on the use of sonidegib in adult patients with laBCC. Document major safety parameters such as on treatment deaths, adverse events (AEs)/ serious adverse events (SAEs) and discontinuation secondary to AEs.

Condition or disease Intervention/treatment
Basal Cell Carcinoma Drug: sonidegib

Detailed Description:
This is a non-interventional, multinational, multi-center post-authorization safety study (PASS), to assess the safety of sonidegib administered in routine clinical practice in patients with laBCC who are not amendable to curative surgery or radiation therapy. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a specific visit schedule. For this study, each enrolled patient will be followed up for 3 years after enrollment.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-interventional, Multi-national, Multi-center Post-authorization Safety Study (PASS) to Assess the Long Term Safety and Tolerability of Odomzo (Sonidegib) Administered in Patients With Locally Advanced Cell Carcinoma (laBCC)
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Sonidegib

Group/Cohort Intervention/treatment
Sonidegib
Patients with laBCC undergoing sonidegib treatment in routine clinical practice
Drug: sonidegib
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
Other Name: LDE225




Primary Outcome Measures :
  1. Proportion of patients with AEs/SAEs [ Time Frame: 3 years ]
    including on-treatment deaths and discontinuation due to AEs/SAEs


Secondary Outcome Measures :
  1. Proportion of patients with AEs of special interest (AESI) or populations [ Time Frame: 3 years ]
    in patients with: relevant polymorphism, ≥65 yrs, hepatic or renal impairment, female patients with child bearing potential using anticonceptives, anemia (hemoglobin <9 g/dL), recent myocardial ischemia or cardiac failure, concomitant medications with known risk of creatine kinase elevation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with laBCC undergoing treatment with sonidegib.
Criteria

Inclusion Criteria:

  • Written informed consent or equivalent document (e.g., written information) as per country regulation
  • Patients aged 18 years or older with a diagnosis of laBCC who are not amenable to curative surgery or radiation therapy
  • Patients must be treated with sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
  • Sonidegib treatment must be started either at the first visit for this study or prior to study entry.

Exclusion Criteria:

  • Patients treated with any hedgehog pathway inhibitor besides sonidegib within 3 months prior to study entry
  • Patients currently enrolled in an interventional clinical trial
  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SmPC)
  • Pregnancy and breast-feeding
  • Women of childbearing potential who do not comply with the Odomzo Pregnancy Prevention Programme (as defined in sections 4.4 and 4.6 of the approved SmPC).
  • Male patients who are unable to follow or comply with the required contraception measures (as defined in sections 4.4 and 4.6 of the approved SmPC).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066504


Contacts
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Contact: Ralf Gutzmer 4951153207672 Gutzmer.Ralf@mh-hannover.de

Locations
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Germany
Katholisches Klinikum Bochum St. Josef-Hospital Recruiting
Bochum, Germany
Elbe Kliniken Stade - Buxtehude GmbH Active, not recruiting
Buxtehude, Germany
DRK-Krankenhaus Chemnitz-Rabenstein Recruiting
Chemnitz, Germany, '09117
Helios Klinikum Active, not recruiting
Erfurt, Germany, 99089
Universitaetsklinikum Essen Not yet recruiting
Essen, Germany
SRH Wald-Klinikum Recruiting
Gera, Germany, 07548
Medizinische Hochschule Hannover Active, not recruiting
Hannover, Germany, '30625
Universitaets-Hautklinik Kiel Active, not recruiting
Kiel, Germany
Hautklinik (Dermatology) Ludwigshafen Active, not recruiting
Ludwigshafen, Germany
Universitaetsklinikum Schleswig-Holstein Recruiting
Luebeck, Germany
Fachklinik Muenster-Hornheide Active, not recruiting
Münster, Germany, 48157
Helios St. Elisabeth Klinik Active, not recruiting
Oberhausen, Germany, 46045
Harzklinikum Dorothea Christiane Erxleben GmbH Active, not recruiting
Quedlinburg, Germany, 06484
Universitaetsklinikum Tuebingen Active, not recruiting
Tuebingen, Germany
Switzerland
Inselspital Active, not recruiting
Bern, Switzerland
Sponsors and Collaborators
Sun Pharmaceutical Industries Limited
Investigators
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Principal Investigator: Ralf Gutzmer Haut-Tumor-Zentrum Hannover

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Responsible Party: Sun Pharmaceutical Industries Limited
ClinicalTrials.gov Identifier: NCT04066504    
Other Study ID Numbers: CLDE225A2404
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: September 2019
Keywords provided by Sun Pharmaceutical Industries Limited:
locally advanced basal cell carcinoma
laBCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell