Evaluate Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs (MACS2002)

Novartis

Status and phase: Completed; Phase 1

Conditions: Neuroendocrine Tumors

Treatments: Drug: RAD001; Drug: SOM230

Study type: Interventional

Funder types: Industry

Identifiers

NCT01590199

CRAD001KDE47

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

RAD001 + SOM230

Experimental group

Treatment:

Drug: SOM230

Drug: RAD001