Last updated: 11/03/2018 20:57:03
Pazopanib Sarcoma Named Patient Programme Chart ReviewSPIRE
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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)
No location data available.
Study documents
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
Finalized
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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