Solid Tumours
Conditions
Keywords
Pharmacokinetics, Safety, MET, Bioavailability, Patients, GSK1363089A, GSK1363089G, GSK1363089, Relative
Brief summary
Study to compare 2 different chemical forms of GSK1363089.
Interventions
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).
Sponsors
Study design
Eligibility
Inclusion criteria
* Histologically or cytologically confirmed diagnosis of solid tumor malignancy. * 18 years old with ECOG of 0-1. * female subject who is not pregnant * Male subjects must agree to use contraception methods * Able to swallow and retain oral medication. * The subject will refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study. * QTcB or QTcF \< 470 msec. * Bilirubin = 1.5mg/dl, AST, ALT, ALP \<2X ULN in absence of malignant disease in the liver or \<5X ULN in case of liver involvement by the tumor. * Serum Creatinine \<1.5mg/dL Exclusion Inclusion: * The subject has received anticancer treatment. * The subject has participated in a clinical trial and has received an investigational product within 21 days. * The subject has known brain metastases. * The subject has uncontrolled intercurrent illness. * History of sensitivity to any of the study medications, or components. * The subject is known to be positive for the human immunodeficiency virus (HIV). * Subjects who have had partial or complete gastrectomy. * Pregnant females as determined by positive ß-hCG test at screening or prior to dosing. * Lactating females. * Unwillingness or inability to follow the procedures outlined in the protocol.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
Countries
United States