A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00742131|
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumours||Drug: GSK1363089||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors|
|Actual Study Start Date :||March 17, 2005|
|Actual Primary Completion Date :||May 13, 2008|
|Actual Study Completion Date :||August 29, 2011|
Experimental: Subjects receiving GSK1363089
Eligible subjects will receive GSK1363089 administered orally as a cinnamon-flavored liquid or as solid capsules with the starting dose for cohort 1 as 0.1 milligram/kilogram. Subjects in cohorts 1, 2, and 3A will receive GSK1363089 in the liquid formulation, while Cohorts 3B, 4, 5, 6, 7, and 8 will receive GSK1363089 in the solid capsule formulation.
GSK1363089 will be administered orally as a cinnamon-flavored liquid (250 milligrams of GSK1363089 in 50 milliliters liquid [5 milligrams/milliliter] or 1000 milligrams of GSK1363089 in 50 milliliters liquid [20 milligrams/milliliter]) or as solid capsules of 20, 100, and/or 200 milligrams.
- To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors [ Time Frame: 3 years ]
- To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742131
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|