Last updated: 11/07/2018 11:13:44

Pazopanib Sarcoma Cost Effectiveness Model

GSK study ID
116947
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 Cost Effectiveness Model
Trial description: A cost effectiveness model was developed in order to understand how pazopanib compared to other commonly used drugs following the failure of first line chemotherapy to treat advanced soft tissue sarcoma (aSTS) in terms of cost effectiveness. In order to compare cost effectiveness, it was necessary to establish the relative efficacy of available therapies based on trial data. A systematic review identified a limited number of Phase II trials providing evidence for the efficacy of these comparators. However, the lack of a common comparator to link pazopanib to these comparators meant that it was not feasible to perform an adjusted indirect comparison of efficacy, allowing for the adjustment for any differences in study population baseline characteristics (e.g. differences in histological subtypes included or baseline performance status). This meant a simple direct comparison was the most feasible way to compare efficacy of these different therapies. In order to maximize the robustness of this unadjusted indirect comparison, a meta-analysis was performed in order to synthesize all available data when more than one trial was available to support a comparator, as was the case for trabectedin and gemcitabine in combination with docetaxel.
It was acknowledged in advance that indirectly comparing the efficacy of these active therapies to pazopanib had the potential to be biased due to the fact that different patient subpopulations were used in individual trials. But keeping in mind this shortcoming, pooling the efficacy data for comparators allowed us to make use of the available evidence to provide the best estimate for efficacy of comparators of pazopanib in aSTS at this time.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

incremental cost per quality adjusted life year gained (QALY)

Timeframe: annual

Secondary outcomes:

Quality adjusted life years (QALYs)

Timeframe: 10 years

Life expectancy

Timeframe: 10 years

Progression-free LYs (PFLYs)

Timeframe: 10 years

Post-progression life years (PPLYs)

Timeframe: 10 years

Cost of treatment

Timeframe: 10 years

Interventions:
  • Drug: Ifosfamide
  • Drug: Gemcitabine + Docetaxel
  • Drug: Trabectedin
  • Drug: Gemcitabine
  • Enrollment:
    447
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Amdahl J, Manson S, Isbell R, Chit A, Diaz J, Lewis L, Delea T.Cost Effectiveness of Pazopanib in Advanced Soft Tissue Sarcoma in the United Kingdom.Sarcoma.2014;
    Medical condition
    Sarcoma, Soft tissue
    Product
    pazopanib
    Collaborators
    Not applicable
    Study date(s)
    October 2011 to June 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • Trials were identified using a systematic literature review of published studies looking at aSTS patients who had failed 1L doxorubicin and/or ifosfamide (the 1L standard of care)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    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
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2012-21-06

    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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