Last updated: 11/04/2018 13:22:50

A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes

GSK study ID
VEG10007
See study documents
Clinicaltrials.gov ID
NCT00401583
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 Multi-center, Open-Label, Multiple-probe Drug Interaction Study to Determine the Effects of GW786034 on the Metabolism of Cytochrome P450 Probe Drugs in Patients with Solid Tumors
Trial description: This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

To investigate the potential of GW786034 to inhibit or induce various CYP450 enzymes.

Timeframe: throughout the study

Secondary outcomes:

Safety of co-administration of 800 mg daily GW786034 and CYP450 probe drugs. To describe GW786034 steady-state pharmacokinetics on this once daily dosing regimen.

Timeframe: throughout the study

Interventions:
  • Drug: GW786034 (pazopanib)
  • Drug: Probe drugs
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Goh BC, Reddy NJ, Dandamudi U, Laubscher KH, Peckham T, Hodge JP, Suttle AB, Arumugham T, Xu Y, Xu CF, Lager J, Dar M, Lewis LD. An Evaluation of the Drug Interaction Potential of Pazopanib, an Oral Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor, Using a Modified Cooperstown 5+1 Cocktail in Patients With Advanced Solid Tumors. [Clin Pharmacol Ther]. 2010;88(5):652-659.
    Goh BC, Reddy NJ, Dandamudi U, Laubscher KH, Peckham T, Hodge JP, Suttle AB, Arumugham T, Xu Y, Xu CF, Lager J, Dar M, Lewis LD. An Evaluation of the Drug Interaction Potential of Pazopanib, an Oral Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitor, Using a Modified Cooperstown 5+1 Cocktail in Patients With Advanced Solid Tumors. Clin Pharmacol Ther. 2010;88(5):652-659.
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    July 2006 to February 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Histologically or cytologically confirmed diagnosis of advanced solid tumors.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days.
    • Poorly controlled hypertension.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Histologically or cytologically confirmed diagnosis of advanced solid tumors.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Adequate bone marrow, renal, lung, and liver function.
    • A female subject must not be pregnant and will agree not to become pregnant during the trial
    Exclusion criteria:
    • Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days.
    • Poorly controlled hypertension.
    • Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
    • Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months.
    • Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents). Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug.
    • History of brain metastases.
    • Has narrow-angle glaucoma which is a contraindication to midazolam use.
    • History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months.
    • A history of bleeding problems.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Lebanon, New Hampshire, United States, 03756
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    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
    2008-20-02

    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 VEG10007 can be found on the GSK Clinical Study Register.
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