A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumours

In brief

Study to compare 2 different chemical forms of GSK1363089.

Key facts

Study ID: NCT00742261
Run by: GlaxoSmithKline
People needed: 12
Starts: 2008-08-11
Expected to finish: 2009-06-24
Last updated by the study team: 2017-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

Where it is running

GSK Investigational Site — Detroit, Michigan, United States
GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.