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A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00742261
First Posted: August 27, 2008
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
Study to compare 2 different chemical forms of GSK1363089.

Condition Intervention Phase
Solid Tumours Drug: GSK1363089 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Actual Study Start Date: August 11, 2008
Study Completion Date: June 24, 2009
Primary Completion Date: June 24, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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:
  • GSK1363089G
  • GSK1363089A

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Michigan
GSK Investigational Site
Detroit, Michigan, United States, 48201
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: MET111516
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00742261     History of Changes
Other Study ID Numbers: MET111516
First Submitted: August 26, 2008
First Posted: August 27, 2008
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.
URL: http://

Keywords provided by GlaxoSmithKline:
Pharmacokinetics
Safety
MET
Bioavailability
Patients
GSK1363089A
GSK1363089G
GSK1363089
Relative