A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: GSK1363089

• Registration Number: NCT00742261
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Study to compare 2 different chemical forms of GSK1363089.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-11
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Primary Completion: 2009-06-24
• Study Completion: 2009-06-24
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-05
• Last Update Posted: 2017-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GSK1363089	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Houston, Texas, United States