Clinical trial · Interventional
Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study
NCT01263353CI-TRIAL-00049022COOPERATE-1completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic gastroenteropancreatic or pulmonary neuroendocrine Tumors (NET).
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 |
|---|---|---|---|
| Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System | Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Everolimus followed by Pasireotide LAR + Everolimus | Drug | — | UNRESOLVED |
| Pasireotide LAR followed by Pasireotide LAR + Everolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Functional tumors, pre-treated
- interventionNames
- Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
- type
- EXPERIMENTAL
- label
- Functional tumors, treatment naïve
- interventionNames
- Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
- type
- EXPERIMENTAL
- label
- Nonfunctional tumors, pretreated 1
- interventionNames
- Drug: Pasireotide LAR followed by Pasireotide LAR + Everolimus
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor * Progressive disease within last 12 months (only patients with nonfunctional tumors) * Documented liver metastasis * Measurable disease per RECIST determined by multiphase MRI or triphasic CT Exclusion Criteria: * Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms * Previous treatment with mTOR inhibitors or pasireotide * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Women who are pregnant or lactating Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.