Clinical trial · Interventional
A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors
NCT00742261CI-TRIAL-00028526completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study to compare 2 different chemical forms of GSK1363089.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumours | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GSK1363089 | Drug | Foretinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GSK1363089
- 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).
- interventionNames
- Drug: GSK1363089
Primary outcomes (1)
- 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 (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDNaing 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