Gastroenteropancreatic Neuroendocrine Tumor of the Pulmonary ot Gastroenteropancreatic System
Conditions
Keywords
Carcinoid tumor,, Gastroenteropancreatic Neuroendocrine Tumors,, Pulmonary Neuroendocrine Tumors,, pasireotide LAR,, SOM230 LAR,, everolimus,, RAD001,, Advanced Neuroendocrine Tumor,, Gastroenteropancreatic System
Brief summary
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).
Interventions
DRUGPasireotide LAR followed by Pasireotide LAR + Everolimus
DRUGEverolimus followed by Pasireotide LAR + Everolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of grade 1/2 advanced pulmonary or gastroenteropancreatic neuroendocrine tumor * Progressive disease within last 12 months (only patients with nonfunctional tumors) * Documented liver metastasis * Measurable disease per RECIST determined by multiphase MRI or triphasic CT
Exclusion criteria
* Previous treatment with radiolabeled somatostatin analogs within 12 months prior to reporting baseline symptoms * Previous treatment with mTOR inhibitors or pasireotide * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Women who are pregnant or lactating Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate safety and tolerability of pasireotide LAR and/or everolimus in patients with advanced metastatic NET | 15 months |
| To assess pharmacokinetic exposures of pasireotide LAR and everolimus during monotherapy and in combination therapy | 15 months |
| To assess potential drug-drug interactions between pasireotide and everolimus during combination therapy | 12 months |
| To assess symptom control (bowel movements and flushing episodes) with pasireotide LAR in combination with everolimus in patients with functioning tumors | 15 months |
| To assess the biochemical response (chromograninA, CgA) to pasireotide LAR in combination with everolimus | 15 months |
Countries
Germany
Outcome results
None listed