Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs
- Registration Number
- NCT01590199
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RAD001 + SOM230 RAD001 - RAD001 + SOM230 SOM230 -
- Primary Outcome Measures
Name Time Method Number of Participants with abnormal laboratory and ECG results as a Measure of Safety and Tolerability up to 4 years Number of Participants with Adverse Events and Serious Adverse Enents as a Measure of Safety and Tolerability up to 4 years
- Secondary Outcome Measures
Name Time Method best overall response up to 4 years investigator-assessed progression free survival (PFS) up to 4 years
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Muenster, Germany