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Skin cancer drug sonidegib under safety watch in Real-World study

NCT ID NCT04066504

Knowledge-focused Sponsor: Sun Pharmaceutical Industries Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at the long-term safety of the drug sonidegib in 323 adults with a type of skin cancer called locally advanced basal cell carcinoma. Participants took a daily 200 mg pill, and researchers tracked side effects, serious events, and deaths. The goal was to gather real-world safety data, not to test if the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sonidegib (a drug taken as a daily pill)
What this could lead to
If successful, this study will provide important safety information to help doctors better manage patients on sonidegib.
What could go wrong
This is an observational study, not a treatment trial, so it does not test if sonidegib works. It only monitors side effects in a real-world setting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

323 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients diagnosed with laBCC undergoing treatment with sonidegib.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

basal cell carcinoma skin basal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Basal cell carcinoma

Contacts and locations

Locations

  • AOU Maggiore della Carità - Università del Piemonte Orientale

    Novara, Italy

  • ASL1 Avezzano-Sulmona-L'Aquila

    L’Aquila, Italy

  • ASST Spedali Civili di Brescia

    Brescia, Italy

  • Azienda Toscana Centro - Università di Firenze

    Florence, Italy

  • Complejo Hospitalario Universitario de Pontevedra

    Pontevedra, 36001, Spain

  • Elbe Kliniken Stade - Buxtehude GmbH

    Buxtehude, Germany

  • Fachklinik Muenster-Hornheide

    Münster, 48157, Germany

  • Forndazione I.R.C.C.S. Istituto nazionale dei tumori

    Milan, 20133, Italy

  • Harzklinikum Dorothea Christiane Erxleben GmbH

    Quedlinburg, 06484, Germany

  • Helios Klinikum

    Erfurt, 99089, Germany

  • Helios St. Elisabeth Klinik

    Oberhausen, 46045, Germany

  • Hospital Clínic de Barcelona

    Barcelona, 8036, Spain

  • Hospital General Universitari València

    Valencia, 46014, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 8916, Spain

  • Hospital Universitario La Fe

    Valencia, 46026, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • I.R.C.C.S Istituto Tumori "Giovanni Paolo II"

    Bari, Italy

  • IDI

    Roma, 00167, Italy

  • Inselspital

    Bern, Switzerland

  • Ist. Scien. Romagnolo per lo Studio e la Cura dei Tumori - IRST

    Meldola, 47014, Italy

  • Istituto Tumori Napoli Fondazione G. Pascale

    Naples, 80131, Italy

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • Katholisches Klinikum Bochum St. Josef-Hospital

    Bochum, Germany

  • Klinikum Darmstadt GmbH

    Darmstadt, 64297, Germany

  • Klinikum Ludwigshafen gGmbH

    Ludwigshafen, Germany

  • Klinikum rechts der Isar

    München, 80802, Germany

  • Medizinische Hochschule Hannover

    Hanover, '30625, Germany

  • Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • SRH Wald-Klinikum

    Gera, 07548, Germany

  • Universitaets-Hautklinik Kiel

    Kiel, Germany

  • Universitaetsklinikum Essen

    Essen, Germany

  • Universitaetsklinikum Schleswig-Holstein

    Lübeck, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Germany

  • Università Cattolica del Sacro Cuore

    Roma, 00168, Italy

  • Università Degli Studi di Napoli Federico II

    Naples, Italy

  • Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden

    Dresden, 1307, Germany

  • Universitätsklinik Magdeburg

    Magdeburg, 39120, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79104, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsspital Zürich

    Zurich, CH- 8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.