Last updated: 11/04/2018 09:11:47

A bioavailability study of GSK1363089 in subjects with Solid Tumors

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GSK study ID
MET111516
See study documents
Clinicaltrials.gov ID
NCT00742261
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of two forms ofGSK1363089 in Subjects with Solid Tumors
Trial description: Study to compare 2 different chemical forms of GSK1363089.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

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:

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

Interventions:
Drug: GSK1363089
Enrollment:
12
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
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]. 2010;[published online].
Naing A., et al (2010). A Comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in subjects with solid tumors. Invest New Drugs (2010) 30: 327-334.
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;30(1):327-334.
Medical condition
Solid Tumours
Product
foretinib
Collaborators
Not applicable
Study date(s)
August 2008 to June 2009
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion Criteria:
  • Histologically or cytologically confirmed diagnosis of solid tumor malignancy.
Inclusion and exclusion criteria
Inclusion 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Status
Study Complete
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Location
GSK Investigational Site
Detroit, Michigan, United States, 48201
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2009-24-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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Additional information
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