Status:
COMPLETED
A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study to compare 2 different chemical forms of GSK1363089.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
August 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00742261
Start Date
August 11 2008
End Date
June 24 2009
Last Update
July 7 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Detroit, Michigan, United States, 48201
2
GSK Investigational Site
Houston, Texas, United States, 77030-4009