A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Solid Tumours Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742261
• Other study ID #: MET111516
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: July 5, 2017
• Start date: August 11, 2008
• Est. completion date: June 24, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to compare 2 different chemical forms of GSK1363089.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 24, 2009
• Est. primary completion date: June 24, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumours

Intervention

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).

Locations

Country	Name	City	State
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Naing A, Kurzrock R, Adams LM, Kleha JF, Laubscher KH, Bonate PL, Weller S, Fitzgerald C, Xu Y, LoRusso PM. A comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in patients with solid tumors. Invest New Drugs. 2012 Feb;30(1):327-34. doi: 10.1007/s10637-010-9536-x. Epub 2010 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study MET111516 can be found on the GSK Clinical Study Register.