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OpenTrials
Completed

NCT Number: NCT00742261

A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Study to compare 2 different chemical forms of GSK1363089.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK1363089

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 27, 2008
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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