Clinical trial NCT00742261: A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
Official title: An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumours
Keywords: Pharmacokinetics
Safety
MET
Bioavailability
Patients
GSK1363089A
GSK1363089G
GSK1363089
Relative
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to compare 2 different chemical forms of GSK1363089.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study.
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.