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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Novartis Investigative Site
Bad Berka, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Münster, Germany
Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET
Time frame: 3 months
Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET
Time frame: 15 months
To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy
Time frame: 15 months
To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy
Time frame: 12 months
To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors
Time frame: 15 months
To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus
Time frame: 15 months
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