Last updated: 11/04/2018 13:08:10

Part A: Radiolabel study with GW786034 Part B: Single dose of GW786034

GSK study ID
VEG10004
Clinicaltrials.gov ID
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: An Open-Label, Two-Part Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Pazopanib (GW786034) and the Absorption, Distribution, Metabolism and Elimination of a Single Oral [14C] Labeled Dose of Pazopanib in Subjects with Solid Tumor Malignancies
Trial description: To study the absorption, distribution, metabolism and excretion of GW786034, and the absorption of a single IV dose of GW786034
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Part A: excretion of radioactivity

Timeframe: over 168 hrs

Part B: Plasma pazopanib, clearance (CL) and AUC(0-t), AUC(0-8),Cmax and half-life (t1/2) pazopanib and pazopanib metabolites (GSK 1268992, GSK1268997, GSK1071306 and GW700201)

Timeframe: over 48 hrs

Secondary outcomes:

Part A: Blood and plasma total radioactivity AUC(0-t), AUC(0-8),Cmax and t1/2

Timeframe: over 168 hrs.

Part B: Safety parameters

Timeframe: over 48 hrs.

Blood and plasma total radioactivity AUC(0-t), AUC(0-∞), Cmax and t1/2 following oral administration of 400 mg of [14C]–pazopanib containing approximately 70 µCi of radioactivity.

Timeframe: on Day 15 of Cycle 1.

Samples (for use in a separate study) to characterize and quantify metabolites of pazopanib in plasma, urine and feces.

Timeframe: on Day 15 of Cycle 1.

Blood:plasma ratio of total drug-related material (radioactivity).

Timeframe: on Day 15 of Cycle 1.

Plasma pazopanib AUC(0-t), AUC(0-∞), Cmax, tmax following oral administration of 400 mg of [14C]–pazopanib containing 70 µCi of radioactivity.

Timeframe: on Day 15 of Cycle 1.

Safety parameters: adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory assessments.

Timeframe: on Day 15 of Cycle 1.

Plasma pazopanib AUC(0-24), Cmax, tmax following oral administration of 800 mg pazopanib

Timeframe: on Day 15 of Cycle 1.

Interventions:
  • Drug: GW786034, oral
  • Drug: GW786034, IV
  • Drug: GW786034, radiolabeled oral
  • Enrollment:
    10
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Deng Y, Sychterz C, Suttle B, et al. Metabolism and Disposition of Oral Pazopanib in Patients with Advanced Cancer. Xenobiotica. 2013;43(5):443-53.
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    July 2007 to July 2008
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Subject must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55404
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Recruiting

    Study documents

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

    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
    2008-01-07

    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 VEG10004 can be found on the GSK Clinical Study Register.
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