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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018895-26 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional tumors, pre-treated | Experimental |
| |
| Functional tumors, treatment naïve | Experimental |
| |
| Nonfunctional tumors, pretreated 1 | Experimental |
| |
| Nonfunctional tumors, pretreated 2 | Experimental |
| |
| Nonfunctional tumors, treatment-naïve 1 | Experimental |
| |
| Nonfunctional tumors, treatment-naïve 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide LAR followed by Pasireotide LAR + Everolimus | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate safety and tolerability profile of pasireotide LAR in combination with everolimus in patients with advanced metastatic NET | 3 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bad Berka | 99438 | Germany | |||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CSOM230F2102 can be found on the Novartis Clinical Trial Results Website | View source |
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| Everolimus followed by Pasireotide LAR + Everolimus | Drug |
|
| 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 |
| Berlin |
| 13353 |
| Germany |
| Novartis Investigative Site | Marburg | 35039 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| ID | Term |
|---|---|
| D002276 | Carcinoid Tumor |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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