Last updated: 11/03/2018 20:57:03

Pazopanib Sarcoma Named Patient Programme Chart ReviewSPIRE

GSK study ID
200773
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: Pazopanib Sarcoma Named Patient Programme Chart Review
Trial description: Rationale: The purpose of this study is to understand the clinical outcomes and treatment patterns in patients who participated in the Named Patient Programme for pazopanib in advanced soft tissue sarcoma (aSTS).
Objectives:
Primary Objectives:
- Describe systemic therapy treatment patterns for patients with aSTS who received pazopanib as compassionate use.
- Describe pazopanib treatment duration.
Secondary Objectives:
- Describe pazopanib treatment experience including relative dose intensity (RDI), dose modifications and reason for dose modifications, treatment discontinuation and reason for discontinuations for patients with aSTS.
Data Source/Study Design: Data will be collected via retrospective review of patient medical records. Outcomes of interest included treatment sequencing, pazopanib treatment duration, progression-free survival (PFS), overall survival (OS), clinical benefit (complete response/partial response/stable disease) reasons for treatment discontinuation, and adverse events (AEs) and serious adverse events (SAEs) of special interest.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Systemic therapy treatment patterns for patients with aSTS who received pazopanib as compassionate use.

Timeframe: Aproximately 2 years or From initiation of first systemic therapy to the last systemic therapy recorded in the medical notes

Pazopanib treatment duration

Timeframe: Aproximately 2 years or From initiation to termination of pazopanib therapy

Secondary outcomes:

Relative dose intensity (RDI), dose modifications and reason for dose modifications, treatment discontinuation and reason for discontinuations for patients with aSTS.

Timeframe: Aproximately 2 years or From initiation to termination of pazopanib therapy

Interventions:
  • Drug: Pazopanib
    • Enrollment:
    300
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Sarcoma, Soft tissue
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    August 2013 to November 2014
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Patient received at least one dose of pazopanib as part of the Named Patient Programme at one of the participating study sites during the eligibility period (between 26 August 2011 and 1 August 2013).
    • Patient was 18 years of age or older at the time of enrolment into the Named Patient Programme.
    • Medical chart is missing, empty, or not retrievable.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Patient received at least one dose of pazopanib as part of the Named Patient Programme at one of the participating study sites during the eligibility period (between 26 August 2011 and 1 August 2013).
    • Patient was 18 years of age or older at the time of enrolment into the Named Patient Programme.
    Exclusion criteria:
    • Medical chart is missing, empty, or not retrievable.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    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
    2014-25-11

    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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