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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004456-37 EudraCT Number |
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The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | with food |
|
| 2 | Experimental | without food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6244 | Drug | 75mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess whether food influences the rate and extent of AZD6244 absorption | Day 1 and Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food | Day 1, 2, 3, 8, 9, and 10 | |
| To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies | screening to 30 day post last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Chopra | AstraZeneca | Study Director |
| Jan Schellens | Maastricht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Amsterdam | Netherlands | ||||
| Research Site |
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| Maastricht |
| Netherlands |
| Research Site | Glasgow | United Kingdom |
| Research Site | Headington | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Oxford | United Kingdom |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C517975 | AZD 6244 |
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