Last updated: 11/03/2018 00:37:55

A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

GSK study ID
104450
See study documents
Clinicaltrials.gov ID
NCT00281632
See results summary
EudraCT ID
2005-002962-12
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: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer.
Trial description: This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Best biochemical response (cancer antigen [CA-125])

Timeframe: Baseline to response (up to 3 years)

Secondary outcomes:

Time to biochemical response (CA-125)

Timeframe: Baseline to response (up to 3 years)

Duration of biochemical response (CA-125)

Timeframe: Baseline to response (up to 3 years)

CA-125 doubling time prior to and during treatment with pazopanib

Timeframe: Baseline to doubling of CA-125 (up to 3 years)

Overall response and stable disease (SD)

Timeframe: Baseline to response (up to 3 years)

Median progression-free survival (PFS)

Timeframe: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)

Overall tumor response

Timeframe: Baseline to response (up to 3 years)

Number of participants with the indicated maximum shift from baseline (BL) in diastolic blood pressure

Timeframe: Baseline to response (up to 3 years)

Number of participants with the indicated maximum shift from baseline (BL) in systolic blood pressure

Timeframe: Baseline to response (up to 3 years)

Number of participants with the indicated maximum shift from baseline (BL) in heart rate

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in albumin

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in amylase and lipase

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in total bilirubin and creatinine

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in calcium, glucose, potassium, sodium, and urea

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in thyroxine

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in thyroid stimulating hormone

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in hemoglobin and hematocrit

Timeframe: Baseline to response (up to 3 years)

Mean change from baseline to response in lymphocytes, neutrophils, platelet count, and white blood count

Timeframe: Baseline to response (up to 3 years)

Interventions:
  • Drug: GW786034
    • Enrollment:
    35
    Primary completion date:
    2009-20-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Friedlander M, Hancock KC, Rischin D, Messing M, Stringer CA, Matthys G, Ma B, Hodge JP, Lager JJ. A Phase II, Open-Label Study Evaluating Pazopanib in Patients With Advanced Ovarian Cancer . [Gynecol Oncol]. 2010;119(1):32-37.
    Medical condition
    Peritoneal Cancer, Ovarian Cancer
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    March 2006 to October 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female
    Age
    21+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
    • Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or oxaliplatin).
    • Has psychological, familial, sociological or geographical condition that does not permit compliance with the protocol.
    • Is on a specifically prohibited medication or requires these medications during treatment with GW786034. Exclusion criteria:
    • Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or radiotherapy with in the last 28 days and has not recovered from such prior therapy.
    • Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or higher).
    • Currently taking warfarin.
    • Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78731
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Herston, Queensland, Australia, 4029
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 229899
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bedford, Texas, United States, 76022
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Singapore, Singapore, 119074
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-20-10
    Actual study completion date
    2009-20-10

    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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