Basal Cell CarcinomaNISSONCT04066504
Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma
An observational study of Basal Cell Carcinoma, run by Sun Pharmaceutical Industries Limited at 47 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma
- What is being tested?
- sonidegib
- Type of treatment
- Pill or oral medicine
- How many people
- 323 participants
- Where
- 47 sitesin 4 countries
- Study dates
- 11 Mar 2019to 14 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with laBCC undergoing treatment with sonidegib.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
47 sites in 4 countries.
47 sites in 4 countries
Germany22 sites
Katholisches Klinikum Bochum St. Josef-Hospital
Bochum
Elbe Kliniken Stade - Buxtehude GmbH
Buxtehude
Klinikum Darmstadt GmbH
Darmstadt, 64297
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, 1307
Helios Klinikum
Erfurt, 99089
Universitaetsklinikum Essen
Essen
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79104
SRH Wald-Klinikum
Gera, 07548
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Medizinische Hochschule Hannover
Hanover, '30625
Universitaets-Hautklinik Kiel
Kiel
Universitaetsklinikum Schleswig-Holstein
Lübeck
Klinikum Ludwigshafen gGmbH
Ludwigshafen
Universitätsklinik Magdeburg
Magdeburg, 39120
Johannes Wesling Klinikum Minden
Minden, 32429
Klinikum rechts der Isar
München, 80802
Fachklinik Muenster-Hornheide
Münster, 48157
Helios St. Elisabeth Klinik
Oberhausen, 46045
Harzklinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, 06484
Universitätsklinikum Regensburg
Regensburg, 93053
Universitaetsklinikum Tuebingen
Tübingen
Universitätsklinikum Ulm
Ulm, 89081
Italy12 sites
I.R.C.C.S Istituto Tumori "Giovanni Paolo II"
Bari
ASST Spedali Civili di Brescia
Brescia
Azienda Toscana Centro - Università di Firenze
Florence
Ospedale Policlinico San Martino
Genova, 16132
ASL1 Avezzano-Sulmona-L'Aquila
L’Aquila
Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST
Meldola, 47014
Forndazione I.R.C.C.S. Istituto nazionale dei tumori
Milan, 20133
Istituto Tumori Napoli Fondazione G. Pascale
Naples, 80131
Università Degli Studi di Napoli Federico II
Naples
AOU Maggiore della Carità - Università del Piemonte Orientale
Novara
IDI
Roma, 00167
Università Cattolica del Sacro Cuore
Roma, 00168
Spain11 sites
Hospital Germans Trias i Pujol
Badalona, 8916
Hospital Vall d'Hebron
Barcelona, 8035
Hospital Clínic de Barcelona
Barcelona, 8036
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, 35010
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Universitario La Paz
Madrid, 28046
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, 36001
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, 38010
Hospital General Universitari València
Valencia, 46014
Hospital Universitario La Fe
Valencia, 46026
Switzerland2 sites
Inselspital
Bern
Universitätsspital Zürich
Zurich, CH- 8091
About this study
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)
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.
Read the 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.
- Conditions
- Basal Cell Carcinoma
- Being tested
- sonidegib
- Keywords
- locally advanced basal cell carcinoma, laBCC
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonidegibDrug
Also called LDE225
Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
| Study group | Role | What they receive |
|---|---|---|
| Sonidegib | Patients with laBCC undergoing sonidegib treatment in routine clinical practice Receives: Drug: sonidegib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with AEs/SAEs
including on-treatment deaths and discontinuation due to AEs/SAEs
Measured: 3 years
Secondary outcomes (1)
Proportion of patients with AEs of special interest (AESI) or populations
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start11 Mar 2019
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Gutzmer, Principal investigator, Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066504
- Sponsor's protocol ID
- CLDE225A2404
- Acronym
- NISSO
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2019
- Last updated
- 18 Mar 2026
- Results posted
- No
Publications
Gutzmer R, Leiter U, Mohr P, Kahler KC, Ascierto PA, Scalvenzi M, Peris K, Perez-Pastor GM, Fernandez-de-Misa R, Botella-Estrada R, Hunger RE, Martelli S, Guneli N, Arntz R, Hauschild A. Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma. BMC Cancer. 2024 Nov 14;24(1):1401. doi: 10.1186/s12885-024-13101-z.
PubMed 39538176
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04066504
- Acronym / sponsor ID
- NISSO / CLDE225A2404
- Conditions
- Basal Cell Carcinoma
- Keywords
- locally advanced basal cell carcinoma, laBCC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 26 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonidegib | – | Drug: sonidegibPatients with laBCC undergoing sonidegib treatment in routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with laBCC undergoing treatment with sonidegib.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonidegibAlso: LDE225Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted) | Drug | Sonidegib |
Primary outcome
Proportion of patients with AEs/SAEs
Time frame: 3 years
including on-treatment deaths and discontinuation due to AEs/SAEs
1 secondary outcome
Proportion of patients with AEs of special interest (AESI) or populations
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 39538176Gutzmer R, Leiter U, Mohr P, Kahler KC, Ascierto PA, Scalvenzi M, Peris K, Perez-Pastor GM, Fernandez-de-Misa R, Botella-Estrada R, Hunger RE, Martelli S, Guneli N, Arntz R, Hauschild A. Interim analysis of the multinational, post-authorization safety study (NISSO) to assess the long-term safety of sonidegib in patients with locally advanced basal cell carcinoma. BMC Cancer. 2024 Nov 14;24(1):1401. doi: 10.1186/s12885-024-13101-z.
Related trials for Basal Cell Carcinoma
Enrolling by invitation
TruScore Standalone Clinical Study
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
Not yet recruiting
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
Nodular BCC
RecruitingObservational study
Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice
Basal Cell Carcinoma of Skin, Optical Coherence Tomography (OCT)
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Gutzmer principal investigator
Universitätsklinik für Dermatologie, Venerologie, Allergologie und Phlebologie Johannes Wesling Klinikum Minden Mühlenkreiskliniken Universitätsklinikum der Ruhr-Universität Bochum
47 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma, run by Sun Pharmaceutical Industries Limited at 47 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in Germany, Italy, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with AEs/SAEs (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04066504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.