A Study to Investigate the Bioavailability of Two Forms of GSK1363089 in Subjects With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00742261
First received: August 26, 2008
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

Study to compare 2 different chemical forms of GSK1363089.


Condition Intervention Phase
Solid Tumours
Solid Tumor
Drug: GSK1363089
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: 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).
Other Names:
  • GSK1363089G
  • GSK1363089A

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742261

Locations
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00742261     History of Changes
Other Study ID Numbers: MET111516
Study First Received: August 26, 2008
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pharmacokinetics
Safety
MET
Bioavailability
Patients
GSK1363089A
GSK1363089G
GSK1363089
Relative

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014