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| ID | Type | Description | Link |
|---|---|---|---|
| 002 |
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This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SB-485232 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values. | 11 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - Biologically effective dose based. - Pharmacokinetic endpoints: AUC, Adverse Events, cmax, tmax, and t1/2. - Presence or absence of anti-SB-485232 antibodies. - Pharmacodynamic endpoints. - Radiographic tumor assessments. | 11 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Santa Monica | California | 90404-2104 | United States | ||
| GSK Investigational Site |
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| ID | Term |
|---|---|
| D020382 | Interleukin-18 |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Indianapolis |
| Indiana |
| 46202 |
| United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |