Conditions: Pancreatic Neuroendocrine Tumors (pNET)
Keywords: Pancreatic Neuroendocrine tumors PNET BEZ235 Everolimus
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 62
Healthy volunteers: no

Brief summary:
This was a multicenter, open label, randomized phase II study to evaluate the efficacy and safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate grade pancreatic neuroendocrine tumor (pNET).

Detailed description:
Patients with advanced (unresectable or metastatic), low to intermediate grade (histologically confirmed well and moderately differentiated) pancreatic neuroendocrine tumor (pNET) were randomized to either BEZ235 or everolimus. The study was planned to include 140 patients, with 70 patients in the BEZ235 treatment group and 70 patients in the everolimus treatment group. An interim analysis was conducted on 62 randomized patients. The study was terminated as the BEZ235 treatment did not demonstrate a progression free survival advantage to everolimus treatment.

Arms:
arm 1: Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily) arm 2: Patients received Everolimus 10 mg qd p.o. (by mouth, daily)

Interventions: intervention 1: BEZ235 intervention 2: Everolimus
Intervention descriptions: intervention 1: BEZ235 400 mg bid p.o. (by mouth, twice daily) intervention 2: Everolimus 10 mg qd p.o. (by mouth, daily)

Protocol document: