Clinical trial · Interventional
Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped for not meeting the primary endpoint for PFS.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Islet Cell Tumor | Pancreatic Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus | Drug | Everolimus | ALIAS |
| Pasireotide LAR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paseriotide LAR + Everolimus
- description
- everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
- interventionNames
- Drug: Everolimus
- Drug: Pasireotide LAR
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- everolimus 10 mg once daily po alone
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- Progression-free Survival (PFS) Per Local Radiological Review
- timeFrame
- Once 80 PFS events had occurred aproximately after 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available