A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors

July 5, 2017 updated by: GlaxoSmithKline

An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors

Study to compare 2 different chemical forms of GSK1363089.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • GSK Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-4009
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2008

Primary Completion (Actual)

June 24, 2009

Study Completion (Actual)

June 24, 2009

Study Registration Dates

First Submitted

August 26, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Actual)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET111516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

Study Data/Documents

  1. Dataset Specification
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: MET111516
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe