Clinical trial · Interventional
Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
Extension Study to the "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"
NCT01590199CI-TRIAL-00038156MACS2002completedPhase 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)
This study will evaluate long-term safety and tolerability of pasireotide LAR in combination with everolimus in advanced metastatic NET patients, who who have not progressed during 12 months of combination therapy with pasireotide LAR and everolimus
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 |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
| SOM230 | Drug | Pasireotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001 + SOM230
- interventionNames
- Drug: RAD001
- Drug: SOM230
Primary outcomes (2)
- measure
- Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability
- timeFrame
- up to 4 years
- measure
- Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability
- timeFrame
- up to 4 years
Secondary outcomes (2)
- measure
- investigator-assessed progression free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion and Exclusion Criteria: Patients eligible for inclusion in this extension study have to meet all of the additional inclusion criteria: * The patient must provide a signed Informed Consent Form (ICF) for the extension study prior to any study related procedures * Completion of the whole treatment period of 15 months (3 months monotherapy with either pasireotide LAR or everolimus followed by a 12 months combination of pasireotide LAR/everolimus) in the CSOM230F2102 study * No tumor progression during 12 months of combination therapy with pasireotide LAR and everolimus (checked via radiologically assessment). No intolerable toxicity during combination therapy with pasireotide LAR and everolimus
References
Publications (0)
Data not yet available
No reference posted for this study.