Study identification

PURI

https://redirect.ema.europa.eu/resource/37938

EU PAS number

EUPAS28453

Study ID

37938

Official title and acronym

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). (PASS ODOMZO (Sonidegib))

DARWIN EU® study

No

Study countries

France
Germany
Italy
Spain
Switzerland

Study description

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 status

Ongoing
Research institutions and networks

Institutions

Helios Klinikum Erfurt Erfurt, Germany, Harzklinikum Quedlinburg Quedinburg, Germany, Fachklinik Muenster-Hornheide Münster, Germany, Helios St. Elisabeth Klinik Oberhausen Oberhausen, Germany, SRH Wald-Klinikum Oberhausen Oberhausen, Germany, UKSH, Christian-Albrechts-Universitaet zu Kiel Kiel, Gemany, Elbe Klinikum Buxtehude Buxtehude, Germany, Universitaets-Hautklinik Tuebingen Tübingen, Germany, UKSH, Klinik fuer Dermatologie, Campus Luebeck Lübeck, Germany, NCI France

Contact details

Ralf Gutzmer

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sun Pharmaceutical Industries Ltd
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)