Last updated: 11/04/2018 13:27:38

A Phase I Study of Pazopanib in Adult Patients with Liver Cancer

GSK study ID
VEG107200
See study documents
Clinicaltrials.gov ID
NCT00370513
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase I, Open-Label, Dose-Escalation, Multi-Center Study or Pazopanib (GW786034) in Adult Patients with Hepatocellular Cancer
Trial description: Liver cancer is a good target for anti-angiogenic treatments such as pazopanib. The effect of pazopanib in patients with liver cancer are unknown. This study is designed to evaluate the safety, tolerability and best dose of pazopanib to be given to patient with liver cancer.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Adverse events (AEs) and changes in vital signs and laboratory values. A dose regimen where no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) will define the maximum tolerated dose (MTD).

Timeframe: throughout the study

Secondary outcomes:

Various pharmacokinetic parametersAlpha-fetoprotein (AFP) measurements and scans

Timeframe: throughout the study

Interventions:
  • Drug: pazopanib
    • Enrollment:
    28
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Yau T, Chen PJ, Chan P, Curtis CM, Murphy PS, Suttle AB, Gauvin J, Hodge JP, Dar MM, Poon RT. Phase I Dose-Finding Study of Pazopanib in Hepatocellular Carcinoma: Evaluation of Early Efficacy, Pharmacokinetics, and Pharmacodynamics. [Clin. Cancer Res.]. 2011;17(21):6914-23.
    Medical condition
    Carcinoma, Hepatocellular
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    December 2006 to April 2009
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Diagnosis of advanced liver cancer
    • adequate bone marrow, liver and kidney function
    • Pregnant or breastfeeding
    • Any serious or unstable medical or psychiatric conditions
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of advanced liver cancer adequate bone marrow, liver and kidney function
    • Any local therapy for tumor must have been completed at least 4 weeks prior to enrolling in study
    Exclusion criteria:
    • Pregnant or breastfeeding
    • Any serious or unstable medical or psychiatric conditions
    • History of metastases to central nervous system
    • History of ulcer, inflammatory bowel disease or disease of the gut
    • History of HIV, or uncontrolled infection
    • Have had a cardiac condition or stoke during the past 6 months
    • High blood pressure
    • Have had a blood clot during the past 6 months
    • History of bleeding blood vessels

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Taipei, Taiwan, 100
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Hong Kong, Hong Kong
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2009-08-04

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study VEG107200 can be found on the GSK Clinical Study Register.
    Click here
    Access to clinical trial data by researchers
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