Last updated: 02/06/2020 16:09:15
HO-14-14418 - Outcomes of first-line pazopanib and sunitinib users and sequential use of pazopanib followed by mTORi therapy among patients with advanced/metastatic renal cell carcinoma in a U.S. community oncology setting.
GSK study ID
201360
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: HO-14-14418 - Outcomes of first-line pazopanib and sunitinib users and sequential use of pazopanib followed by mTORi therapy among patients with advanced/metastatic renal cell carcinoma in a U.S. community oncology setting.
Trial description: Separate and sequential real world studies to assess effectiveness of first-line treatment with pazopanib and sunitnib were conducted retrospectively in the US Oncology Network (USON)/McKesson Specialty Health (MSH) community setting in patients with advanced renal cell carcinoma (RCC). In the pazopanib study, clinical outcomes were consistent with those reported in clinical trials. In the sunitinib study, clinical outcomes were inferior to those observed in the pivotal clinical trials, which was attributed to more frequent dose reductions due to toxicities with patients discontinuing from sunitnib therapy sooner than in the clinical trials. This preliminary data also suggested that further investigation on the comparative outcomes of advanced RCC patients that receive first-line pazopanib with those receiving first-line sunitinib may be warranted. Although a phase III study comparing the efficacy of pazopanib versus sunitinib as first-line therapy for advanced/metastatic RCC demonstrated that pazopanib was non-inferior to sunitinib as indicated by a PFS HR of 1.047 (95% confidence interval [CI]: 0.8982-1.2195), it will be useful to understand the outcomes associated with these therapies outside of a controlled setting such as that of a clinical trial. To date, no comparative studies have been conducted to evaluate the real-world effectiveness and safety of pazopanib versus sunitinib in advanced RCC patients treated in the first-line setting. The current study will be a follow up to study HO-13-12943/200210 and proposes to (i) compare outcomes and costs in advanced RCC patients treated with first-line pazopanib or first-line sunitinib, and (ii) assess the patient characteristics, clinical/safety outcomes, treatment patterns, and healthcare resource use (HCRU) associated with progressive advanced RCC in patients treated with first-line pazopanib followed by a sequential mTOR sequence (temsirolimus or everolimus) within the USON/MSH network.All third party trademark rights are the rights of their respective owners.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Healthcare Resource Utilization and Costs
Timeframe: N/A
Demographic and Clinical Characteristics
Timeframe: N/A
Clinical and Safety Outcomes
Timeframe: N/A
Treatment and Utilization Patterns
Timeframe: N/A
Secondary outcomes:
Healthcare Resource Utilization
Timeframe: N/A
Demographic and Clinical Characteristics
Timeframe: N/A
Clinical and Safety Outcomes
Timeframe: N/A
Treatment and Utilization Patterns
Timeframe: N/A
Interventions:
Enrollment:
0
Primary completion date:
2015-24-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib, sunitinib
Collaborators
Not applicable
Study date(s)
August 2015 to November 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Patients who received care at a US Oncology Network site that utilizes the full EHR capacities of the iKM database at the time of treatment.
- Patients with a documented primary diagnosis (search term) of renal cell carcinoma in iKM and who were diagnosed at stage III/IV or were diagnosed at early stage but developed metastatic disease.
- Patients enrolled in a clinical trial.
- Patients diagnosed with and treated for other primary cancers during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients who received care at a US Oncology Network site that utilizes the full EHR capacities of the iKM database at the time of treatment.
- Patients with a documented primary diagnosis (search term) of renal cell carcinoma in iKM and who were diagnosed at stage III/IV or were diagnosed at early stage but developed metastatic disease.
- Patients who received either pazopanib (Cohorts A) and sunitinib (Cohort B) as first line of therapy in the defined study period.
- Patients who received either temsirolimus or everolimus (Cohort C), as second line therapy following first line use of pazopanib during the study time period
- Patients with ≥ 2 visits within the US Oncology Network
- Patients ≥ 18 years of age at first diagnosis of RCC
Exclusion criteria:
- Patients enrolled in a clinical trial.
- Patients diagnosed with and treated for other primary cancers during the study period.
- Patients who are diagnosed with RCC but initiated a first-line treatment other than pazopanib or sunitinib.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2015-24-11
Actual study completion date
2015-24-11
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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