A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Solid Tumours

Treatments: Drug: GSK1363089

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742261

MET111516

Details and patient eligibility

About

Study to compare 2 different chemical forms of GSK1363089.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 1 patient group

GSK1363089

Experimental group

Description:

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).

Treatment:

Drug: GSK1363089