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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2025
  • participants needed
    300
  • sponsor
    Sun Pharmaceutical Industries Limited
Updated on 25 March 2022
carcinoma
sonidegib 200 mg
sonidegib

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.

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.

Details
Condition Basal Cell Carcinoma
Treatment Sonidegib
Clinical Study IdentifierNCT04066504
SponsorSun Pharmaceutical Industries Limited
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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