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This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving GSK1363089 | Experimental | Eligible subjects will receive GSK1363089 administered orally as a cinnamon-flavored liquid or as solid capsules with the starting dose for cohort 1 as 0.1 milligram/kilogram. Subjects in cohorts 1, 2, and 3A will receive GSK1363089 in the liquid formulation, while Cohorts 3B, 4, 5, 6, 7, and 8 will receive GSK1363089 in the solid capsule formulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1363089 | Drug | GSK1363089 will be administered orally as a cinnamon-flavored liquid (250 milligrams of GSK1363089 in 50 milliliters liquid [5 milligrams/milliliter] or 1000 milligrams of GSK1363089 in 50 milliliters liquid [20 milligrams/milliliter]) or as solid capsules of 20, 100, and/or 200 milligrams. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089 | 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20472683 | Background | Eder JP, Shapiro GI, Appleman LJ, Zhu AX, Miles D, Keer H, Cancilla B, Chu F, Hitchcock-Bryan S, Sherman L, McCallum S, Heath EI, Boerner SA, LoRusso PM. A phase I study of foretinib, a multi-targeted inhibitor of c-Met and vascular endothelial growth factor receptor 2. Clin Cancer Res. 2010 Jul 1;16(13):3507-16. doi: 10.1158/1078-0432.CCR-10-0574. Epub 2010 May 14. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| MET111647 | Informed Consent Form | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| C544831 | GSK 1363089 |
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| Results for study MET111647 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111647 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |