Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | June 2011 |
| End Date: | August 2015 |
| Contact: | Novartis Pharmaceuticals |
| Phone: | +1(800)340-6843 |
A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study
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
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
We found this trial at
7
sites
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Charlotte, North Carolina 28203
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