Last updated: 11/07/2018 11:13:44
Pazopanib Sarcoma Cost Effectiveness Model
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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;
- 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)
Inclusion and exclusion criteria
Inclusion criteria:
- 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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