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A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00742261
Enrollment
12
Registered
2008-08-27
Start date
2008-08-11
Completion date
2009-06-24
Last updated
2017-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumours

Keywords

Pharmacokinetics, Safety, MET, Bioavailability, Patients, GSK1363089A, GSK1363089G, GSK1363089, Relative

Brief summary

Study to compare 2 different chemical forms of GSK1363089.

Interventions

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).

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study.12 months

Secondary

MeasureTime frame
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.12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026