Overview

Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET

Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
Summary
This study will estimate the treatment effect of everolimus in combination with pasireotide LAR relative to everolimus alone on progression-free survival (PFS) in patients with advanced progressive PNET. A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival (PFS) as per local radiology assessment and was prematurely terminated with the last patient last visit on 19-Feb-2015. However, it is important to note that the data did not reveal any new safety concerns. It was decided to stop the study and this decision was shared with the study sites on 31-Jul-2014.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Everolimus
Pasireotide
Sirolimus
Criteria
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:

- Patients currently requiring somatostatin analog treatment

- Prior therapy with mTOR inhibitors or pasireotide

- Patients with more than 2 prior systemic treatment regimens

- Previous cytotoxic chemotherapy, targeted therapy, somatostatin analogs, or biotherapy
within the last 4 weeks

Other protocol-defined inclusion/exclusion criteria may apply