Conditions: Advanced Neuroendocrine Tumors of Pancreatic Origin
Keywords: Phase III Advanced Neuroendocrine Tumor in adults RAD001 NET everolimus mTOr islet cell neuroendocrine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 410
Healthy volunteers: no

Brief summary:
The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.

Detailed description:

Arms:
arm 1: Participants received 10 mg per day of Everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1). arm 2: Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

Interventions: intervention 1: Everolimus intervention 2: Everolimus Placebo
Intervention descriptions: intervention 1: A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets. intervention 2: a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.

Protocol document: