Last updated: 02/04/2020 16:00:15

Meta-Analysis Plan for liver analyses with GW786034 (pazopanib) treatment in advanced/metastatic renal cell carcinoma and soft tissue sarcoma to support a regulatory post marketing requirement

GSK study ID
200277
See study documents
Clinicaltrials.gov ID
Not applicable
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: Meta-Analysis Plan for liver analyses with GW786034 (pazopanib) treatment in advanced/metastatic renal cell carcinoma and soft tissue sarcoma to support a regulatory post marketing requirement
Trial description: An integrated analysis of the data from pazopanib studies in renal cell carcinoma and soft tissue sarcoma. This analysis is intended to fulfill a post marketing requirement to examine the safety of dose modification of pazopanib and patient rechallenge with pazopanib following hepatoxicity. The analysis will include at least 1500 subjects from VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG20002 and VEG110727.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Liver safety profile

Timeframe: N/A

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Pazopanib
    • Enrollment:
    0
    Primary completion date:
    2013-23-05
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Sarcoma, Soft tissue, Carcinoma, Renal Cell
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    April 2013 to May 2013
    Type
    Observational
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 999 Year
    Accepts healthy volunteers
    none
    • Inclusion criteria:
    • Subjects who have participated on VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG200002, or VEG110727
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Subjects who have participated on VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG200002, or VEG110727
    • Subjects received pazopanib therapy while on the above trials Exclusion criteria:
    • Not having received pazopanib on one of the aforementioned trials.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    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
    2013-23-05
    Actual study completion date
    2013-23-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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