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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-003348-75 | EudraCT Number |
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This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOM230 LAR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection | in patients with acromegaly and in patients with carcinoid disease | Baseline, D7, D35, D63 |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection | in patients with acromegaly and in patients with carcinoid disease. | Baseline, D7, D35, D63 |
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Inclusion criteria for patients with acromegaly:
Exclusion criteria for patients with acromegaly:
Inclusion criteria for patients with carcinoid disease:
Exclusion criteria for patients with carcinoid disease:
Other protocol-defined in- and exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Novartis | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center SC - 4 | Los Angeles | California | 90048 | United States | ||
| Stanford University Medical Center Stanford Cancer Center (3) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24800725 | Result | Petersenn S, Bollerslev J, Arafat AM, Schopohl J, Serri O, Katznelson L, Lasher J, Hughes G, Hu K, Shen G, Resendiz KH, Giannone V, Beckers A. Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. J Clin Pharmacol. 2014 Nov;54(11):1308-17. doi: 10.1002/jcph.326. Epub 2014 May 24. |
| Label | URL |
|---|---|
| Novartis Clinical Trial Results for CSOM230C2110 | View source |
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| Stanford |
| California |
| 94304 |
| United States |
| H. Lee Moffitt Cancer Center & Research Institute Dept.of H.LeeMoffittCC&RI(1) | Tampa | Florida | 33612 | United States |
| University of Texas/MD Anderson Cancer Center Gastrointestinal Med. Oncology | Houston | Texas | 77030-4009 | United States |
| Novartis Investigative Site | Brussels | 1200 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | London | Ontario | N6A 4L6 | Canada |
| Novartis Investigative Site | Toronto | Ontario | M5G1X5 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Berlin | 10098 | Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Essen | 45122 | Germany |
| Novartis Investigative Site | Leipzig | 04317 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | Rotterdam | 3015 CE | Netherlands |
| Novartis Investigative Site | Oslo | NO-0379 | Norway |
| ID | Term |
|---|---|
| D002276 | Carcinoid Tumor |
| D000172 | Acromegaly |
| 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 |
| D001849 | Bone Diseases, Endocrine |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C517782 | pasireotide |
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