The trial is: NCT00510068 , A Randomized Double-Blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)
Objectives are: Assess the clinical activity of everolimus plus best supportive care as defined by progression free survival, per Response Evaluation Criteria In Solid Tumors (RECIST) criteria, in patients with advanced Neuroendocrine Tumors. Secondary Outcome Measures: To evaluate the effect of everolimus on other tumor endpoints: objective response rate (Complete Response [CR] and Partial Response [PR]), response duration To compare overall survival (OS) between the study arms. It is based on a phase II trial presented in 2007 ASCO where there was a partial response in 20% of patients, while another 72% of patients achieved disease stabilisation. The median progression-free survival was 59 weeks. Of the patients on the 10-mg dose of RAD001, 8 patients (27%) achieved a partial response according to RECIST criteria; 21 patients (70%) achieved stable disease; median progression-free survival was 62 weeks. Of the 30 patients with carcinoid tumours who were treated with RAD001 (including the 5 mg dose), 4 patients (13%) achieved a partial response according to RECIST criteria; 25 patients (83%) achieved stable disease; median progression-free survival was 64 weeks.
Phase II Study of RAD001 (Everolimus) and Depot Octreotide (Sandostatin LAR) in Advanced Low Grade Neuroendocrine Carcinoma. Abstract 4503, ASCO 2007
Matthew H Kulke Gastrointestinal neuroendocrine tumors: a role for targeted therapies?Endocrine-Related Cancer 14 (2) 207-219, 2007
I Durán et al, New drug development in digestive neuroendocrine tumorsAnnals of Oncology Advance Access published online on February 13, 2007
Annals of Oncology, doi:10.1093/annonc/mdm009