advanced progressive gastro-intestinal or lung carcinoids
Conditions
Brief summary
To evaluate the incidence of SAEs and AEs, physical examination output, laboratory tests results, and cardiologic assessment, during treatment study period.
Detailed description
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.
Interventions
DRUGIPSTYL “120 mg soluzione iniettabile in siringa preriempita”
DRUGMETFORMINA TEVA 850 mg compresse rivestite con film
Sponsors
Fondazione IRCCS Istituto Nazionale Dei Tumori
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the incidence of SAEs and AEs, physical examination output, laboratory tests results, and cardiologic assessment, during treatment study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed