A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

NCT00742261 | Completed Phase 1

• 1 other identifier: MET111516
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Study to compare 2 different chemical forms of GSK1363089.

Conditions

Solid Tumours

Keywords

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

Outcome Measures

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.

  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.

  12 months

Study Arms (1)

GSK1363089

EXPERIMENTAL

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

Interventions

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).

Also known as: GSK1363089G, GSK1363089A

GSK1363089

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of solid tumor malignancy.
• 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
• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Detroit, Michigan, 48201, United States

Location

GSK Investigational Site

Houston, Texas, 77030-4009, United States

Location

Related 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.

  PMID: 20842406 BACKGROUND

Related 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.

MeSH Terms

Interventions

GSK 1363089

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 27, 2008
• Study Start: August 11, 2008
• Primary Completion: June 24, 2009
• Study Completion: June 24, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

US (2)