Last updated: 11/04/2018 13:34:08

Pazopanib (GW786034) In Subjects With Relapsed Or Refractory Multiple Myeloma

GSK study ID
VEG20006
See study documents
Clinicaltrials.gov ID
NCT00256880
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 II, Open-Label Study of Pazopanib (GW786034) in Patients with Relapsed or Refractory Multiple Myeloma
Trial description: The purpose of this study is to determine how effective and safe a new investigational drug is in treating patients with relapsed or refractory multiple myeloma. The treatment involves daily dosing. A patient may continue to receive the treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of drug in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: GW786034
    • Enrollment:
    100
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Prince HM, Honemann D, Spencer A, et al. Vascular endothelial growth factor inhibition is not an effective therapeutic strategy for relapsed or refractory multiple myeloma: a phase 2 study of pazopanib (GW786034). Blood. 2009;113(19):4819-4820.
    Medical condition
    Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    January 2005 to December 2005
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must have diagnosis of relapsed or refractory multiple.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must have diagnosis of relapsed or refractory multiple.
    • bone marrow function [ANC (absolute neutrophil count) greater than 1000/mm3]; platelet count greater than or equal to 75,000/mm3.
    • renal function (calculated creatinine clearance >50 mL.min, albumin less than or equal to 500 mg). Exclusion criteria:
    • Failed more than 3 prior lines of therapy including stem cell transplant.
    • Females who are pregnant or nursing.
    • Unstable blood pressure.
    • Significant heart conditions or history of thrombosis.
    • Any unstable, pre-existing major medical condition or history of other cancers.
    • Have received an investigational drug, chemotherapy, radiation treatment or surgery within 28 days prior to entering the study.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Melbourne, Victoria, Australia, 3050
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Melbourne, Victoria, Australia, 3004
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98109
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27710
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    East Melbourne, Victoria, Australia, 3002
    Status
    Study Complete
    Contact us
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    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
    2005-15-12

    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

    Additional information
    Not applicable
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