Efficacy and Safety of BEZ235 Compared to Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumors
| Status: | Terminated |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2012 |
| End Date: | September 2014 |
Randomized Phase II Study of BEZ235 or Everolimus in Advanced Pancreatic Neuroendocrine Tumors
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).
safety of BEZ235 as compared to everolimus in patients with advanced, low to intermediate
grade pancreatic neuroendocrine tumor (pNET).
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.
(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.
Inclusion Criteria:
- Advanced histologically confirmed well differentiated pancreatic neuroendocrine tumor
- Progressive disease within the last 12 months
- Measurable disease per RECIST Version 1.0 determined by multiphase MRI or triphasic
CT
Exclusion Criteria:
- Prior treatment with mTOR or PI3K inhibitors
- Patients with more than 2 prior systemic treatment regimens
- Previous cytotoxic chemotherapy, targeted therapy, or biotherapy within the last 4
weeks
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
5
sites
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