A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-11

Study Completion Date

2009-06-24

Brief Summary

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Study to compare 2 different chemical forms of GSK1363089.

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Detailed Description

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Conditions

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Solid Tumours

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

GSK1363089

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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GSK1363089G GSK1363089A

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 20842406 (View on PubMed)

Study Documents

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