interventional
N/A
1 country
1
To evaluate the safety of Lanreotide ATG 120 mg in combination with Metformin as number of AEs and SAEs.
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.
April 3, 2024
Actual (reported)To evaluate the incidence of SAEs and AEs, physical examination output, laboratory tests results, and cardiologic assessment, during treatment study period.
To evaluate the efficacy of Lanreotide ATG 120 mg in combination with Metformin on the time to progression (TTP), defined as the time from first study drugs administration (Lanreotide 120 mg plus Metformin) to the first radiological or clinical or biochemical progression or tumor-related death, according to RECIST criteria vs 1.1.
To evaluate the efficacy of Lanreotide ATG 120 mg in combination with Metformin on symptomatic response.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
IPSTYL “120 mg soluzione iniettabile in siringa preriempita”
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
METFORMINA TEVA 850 mg compresse rivestite con film
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
IPSTYL “120 mg soluzione iniettabile in siringa preriempita”
Named ingredient: lanreotide
View registry recordMETFORMINA TEVA 850 mg compresse rivestite con film
Named ingredient: Metformin hydrochloride
View registry recordFondazione IRCCS Istituto Nazionale Dei Tumori
Milan, 20133, Italy
Clinical Trials Center
First Submitted
April 3, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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