Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs

• Status: Completed
• Trial end date: 2018-09-11
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Pasireotide; Sirolimus

Criteria

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