Patients with somatostatin receptor positive, well-differentiated G2 and G3, advanced GEP NETs
Conditions
Brief summary
Progression Free Survival (PFS): Time from randomization to the first line progression (centrally assessed according to RECIST 1.1) or death due to any cause
Detailed description
ORR: Rate of patients with best overall response of partial response (PR) or complete response (CR) (centrally assessed according to RECIST 1.1), Time to decline (TTD) by 10 points from baseline in the following scores measured by the EORTC QLQ-C30 questionnaire: global health status, diarrhea, fatigue and pain
Interventions
Sponsors
Advanced Accelerator Applications
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS): Time from randomization to the first line progression (centrally assessed according to RECIST 1.1) or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR: Rate of patients with best overall response of partial response (PR) or complete response (CR) (centrally assessed according to RECIST 1.1), Time to decline (TTD) by 10 points from baseline in the following scores measured by the EORTC QLQ-C30 questionnaire: global health status, diarrhea, fatigue and pain | — |
Countries
France, Germany, Italy, Netherlands, Spain
Outcome results
None listed