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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumours, Solid Tumor

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

MET111516

NCT ID:

NCT00742261

Start Date:

August 2008

Completion Date:

June 2009

Related Keywords:

  • Solid Tumours
  • Solid Tumor
  • Pharmacokinetics
  • Safety
  • MET
  • Bioavailability
  • Patients
  • GSK1363089A
  • GSK1363089G
  • GSK1363089
  • Relative
  • Neoplasms

Name

Location

GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteRoyal Oak, Michigan  48073