A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Study Overview
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Brief Summary
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Study to compare 2 different chemical forms of GSK1363089.

Official Title
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An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors

Conditions
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Solid Tumours

Intervention / Treatment
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* Drug: GSK1363089


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GSK1363089<br>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). | Drug: GSK1363089<br>* 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).<br>* Other names: GSK1363089A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety, MET, Bioavailability, Patients, GSK1363089A, GSK1363089G, GSK1363089, Relative