A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
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ClinicalTrials.gov Identifier: NCT00742261 |
Recruitment Status :
Completed
First Posted : August 27, 2008
Last Update Posted : July 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumours | Drug: GSK1363089 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors |
Actual Study Start Date : | August 11, 2008 |
Actual Primary Completion Date : | June 24, 2009 |
Actual Study Completion Date : | June 24, 2009 |
Arm | Intervention/treatment |
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Experimental: 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).
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Drug: 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).
Other Names:
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- Pharmacokinetic parameters,Cmax, AUC(0-t), AUC(0-8)] from free base and bisphosphate salt formulations in Part 1 of the study. [ Time Frame: 12 months ]
- 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. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00742261
United States, Michigan | |
GSK Investigational Site | |
Detroit, Michigan, United States, 48201 | |
United States, Texas | |
GSK Investigational Site | |
Houston, Texas, United States, 77030-4009 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Study Data/Documents: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00742261 |
Other Study ID Numbers: |
MET111516 |
First Posted: | August 27, 2008 Key Record Dates |
Last Update Posted: | July 7, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site. |
Pharmacokinetics Safety MET Bioavailability Patients |
GSK1363089A GSK1363089G GSK1363089 Relative |
Neoplasms |