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

September 12, 2023 updated by: Sun Pharmaceutical Industries Limited

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bochum, Germany
        • Katholisches Klinikum Bochum St. Josef-Hospital
      • Buxtehude, Germany
        • Elbe Kliniken Stade - Buxtehude GmbH
      • Darmstadt, Germany, 64297
        • Klinikum Darmstadt GmbH
      • Dresden, Germany, 1307
        • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
      • Erfurt, Germany, 99089
        • Helios Klinikum
      • Essen, Germany
        • Universitaetsklinikum Essen
      • Freiburg, Germany, 79104
        • Universitätsklinikum Freiburg
      • Gera, Germany, 07548
        • SRH Wald-Klinikum
      • Hamburg, Germany, 20246
        • Universitatsklinikum Hamburg-Eppendorf
      • Hannover, Germany, '30625
        • Medizinische Hochschule Hannover
      • Kiel, Germany
        • Universitaets-Hautklinik Kiel
      • Ludwigshafen, Germany
        • Klinikum Ludwigshafen gGmbH
      • Luebeck, Germany
        • Universitaetsklinikum Schleswig-Holstein
      • Magdeburg, Germany, 39120
        • Universitätsklinik Magdeburg
      • Minden, Germany, 32429
        • Johannes Wesling Klinikum Minden
      • München, Germany, 80802
        • Klinikum Rechts der Isar
      • Münster, Germany, 48157
        • Fachklinik Muenster-Hornheide
      • Oberhausen, Germany, 46045
        • Helios St. Elisabeth Klinik
      • Quedlinburg, Germany, 06484
        • Harzklinikum Dorothea Christiane Erxleben GmbH
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Tuebingen, Germany
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
  • Italy
      • Bari, Italy
        • I.R.C.C.S Istituto Tumori "Giovanni Paolo II"
      • Brescia, Italy
        • ASST Spedali Civili di Brescia
      • Firenze, Italy
        • Azienda Toscana Centro - Università di Firenze
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino
      • L'Aquila, Italy
        • ASL1 Avezzano-Sulmona-L'Aquila
      • Meldola, Italy, 47014
        • Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST
      • Milan, Italy, 20133
        • Forndazione I.R.C.C.S. Istituto nazionale dei tumori
      • Napoli, Italy
        • Università degli Studi di Napoli Federico II
      • Napoli, Italy, 80131
        • Istituto Tumori Napoli Fondazione G. Pascale
      • Novara, Italy
        • AOU Maggiore della Carità - Università del Piemonte Orientale
      • Roma, Italy, 00168
        • Università Cattolica del Sacro Cuore
      • Roma, Italy, 00167
        • IDI
  • Spain
      • Badalona, Spain, 8916
        • Hospital Germans Trias i Pujol
      • Barcelona, Spain, 8036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 8041
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 8035
        • Hospital Vall d'Hebron
      • Las Palmas De Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon Y Cajal
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Pontevedra, Spain, 36001
        • Complejo Hospitalario Universitario de Pontevedra
      • Santa Cruz De Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Valencia, Spain, 46026
        • Hospital Universitario La Fe
      • Valencia, Spain, 46014
        • Hospital General Universitari València
  • Switzerland
      • Bern, Switzerland
        • Inselspital
      • Zürich, Switzerland, CH- 8091
        • Universitatsspital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with laBCC undergoing treatment with sonidegib.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • LDE225

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with AEs/SAEs
Time Frame: 3 years
including on-treatment deaths and discontinuation due to AEs/SAEs
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharmaceutical Industries Limited

Investigators

  • Principal Investigator: Ralf Gutzmer, Haut-Tumor-Zentrum Hannover

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDE225A2404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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