Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study to compare 2 different chemical forms of GSK1363089.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1363089 | Experimental | Two-part study to evlauate the relative bioavailability of GSK1363089 from a free base formulation (GSK1363089G) compared with the biophosphate salt formulation (GSK1363089A) (Part 1) and to assess the safety of the GSK1363089 biophosphate formulation when administered three times a week until disease progression (Part 2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1363089 | Drug | Two-part study to evlauate the relative bioavailability of GSK1363089 from a free base formulation (GSK1363089G) compared with the biophosphate salt formulation (GSK1363089A) (Part 1) and to assess the safety of the GSK1363089 biophosphate formulation when administered three times a week until disease progression (Part 2). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability in Part 1 and 2.• Time to tmax and t½ of GSK1363089in Part 1.• Trough and nominal peak GSK1363089 concentrations during Week 3 of Part 2.• Assess response to therapy in Part 2 of the study. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Inclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Detroit | Michigan | 48201 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20842406 | Background | Naing A, Kurzrock R, Adams LM, Kleha JF, Laubscher KH, Bonate PL, Weller S, Fitzgerald C, Xu Y, LoRusso PM. A comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in patients with solid tumors. Invest New Drugs. 2012 Feb;30(1):327-34. doi: 10.1007/s10637-010-9536-x. Epub 2010 Sep 15. |
| 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 |
|---|---|---|---|
| MET111516 | Dataset Specification | 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C544831 | GSK 1363089 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Houston |
| Texas |
| 77030-4009 |
| United States |
| Results for study MET111516 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 |
| MET111516 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111516 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111516 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111516 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111516 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| MET111516 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |