SYFdcbff9254c8f47cd8f700347492d8966Registry ID: 2024-516797-29-00|Active Not RecruitingPhase 2
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interventional
N/A
1 country
10
To evaluate the compliance to a tailored regimen of sonidegib in patients who have previously obtained CR assuming any inhibitor of the Hedgehog pathway.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 4, 2024
Actual (reported)Proportion of patients maintaining the tailored treatment with sonidegib 12 months after enrolment into the study.
Compliance with the study treatment (number of sonidegib cps assumed/number of sonidegib cps foreseen during the study period).
Proportion of patients maintaining treatment 2 years after achieving CR.
Proportion of patients who experimented relapses after sonidegib interruption for causes other than disease progression at 1 year after achieving CR.
Proportion of patients who experimented relapse after sonidegib interruption for causes other than disease progression at 2 years after achieving CR.
Safety of the tailored sonidegib schedules (schedule 1: 14 days on - 14 days off; schedule 2: 7 days on – 21 days off) measured by CTCAE scale. AEs and SAEs will be described as number of events and percentages, stratified for grade.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Odomzo 200 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Odomzo 200 mg hard capsules
Named ingredient: sonidegib
View registry recordHumanitas Mirasole S.p.A.
Rozzano, 20089, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Novara, 28100, Italy
Paolo Bossi
First Submitted
September 4, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Contact the study team to confirm eligibility.
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, 25123, Italy
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, 80138, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, 16132, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, 34128, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131, Italy
Istituto Europeo Di Oncologia S.r.l.
Milan, 20141, Italy