A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

• Status: Completed
• Trial end date: 2009-06-24
• Target enrollment: 0
• Participant gender: All

Summary

Study to compare 2 different chemical forms of GSK1363089.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.