A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
- Registration Number
- NCT00742261
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Study to compare 2 different chemical forms of GSK1363089.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GSK1363089 GSK1363089 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).
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Houston, Texas, United States