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To assess the safety and efficacy of SU11248 in patients with Neuroendocrine Tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic objective disease response | From screening until disease progression or discontinuation of study |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety (adverse events and lab abnormalities) | From screening until patient death or discontinuation of study | |
| To assess patient-reported outcomes and treatment-related symptoms | From screening until patient death or discontinuation of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35233 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29161241 | Derived | Lamarca A, Barriuso J, Kulke M, Borbath I, Lenz HJ, Raoul JL, Meropol NJ, Lombard-Bohas C, Posey J, Faivre S, Raymond E, Valle JW. Determination of an optimal response cut-off able to predict progression-free survival in patients with well-differentiated advanced pancreatic neuroendocrine tumours treated with sunitinib: an alternative to the current RECIST-defined response. Br J Cancer. 2018 Jan;118(2):181-188. doi: 10.1038/bjc.2017.402. Epub 2017 Nov 21. | |
| 25756398 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| To assess pharmacokinetics and biomarkers | From screening until patient death or discontinuation of study |
| To assess overall survival at 1 year | From screening until patient death or discontinuation of study |
| To assess other measures of antitumor efficacy including TTP and survival | From screening until patient death or discontinuation of study |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Pfizer Investigational Site | Los Angeles | California | 90033-0800 | United States |
| Pfizer Investigational Site | Los Angeles | California | 90033 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115-1705 | United States |
| Pfizer Investigational Site | Pinckneyville | Illinois | 62274 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02114 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02115 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| Derived |
| Zurita AJ, Khajavi M, Wu HK, Tye L, Huang X, Kulke MH, Lenz HJ, Meropol NJ, Carley W, DePrimo SE, Lin E, Wang X, Harmon CS, Heymach JV. Circulating cytokines and monocyte subpopulations as biomarkers of outcome and biological activity in sunitinib-treated patients with advanced neuroendocrine tumours. Br J Cancer. 2015 Mar 31;112(7):1199-205. doi: 10.1038/bjc.2015.73. |
| D009380 | Neoplasms, Nerve Tissue |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |