Last updated: 02/04/2020 15:30:11
First Line and Sequential Use of Pazopanib Followed by Mammalian Target of Rapamycin (mTOR) Inhibitor Therapy among Patients with Advanced/Metastatic Renal Cell Carcinoma in a United States Community Oncology Setting
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: First Line and Sequential Use of Pazopanib Followed by Mammalian Target of Rapamycin (mTOR) Inhibitor Therapy among Patients with Advanced/Metastatic Renal Cell Carcinoma in a United States Community Oncology Setting
Trial description: Retrospective studies and clinical trials have investigated the sequencing of targeted therapies for the treatment of advanced renal cell carcinoma (aRCC). Specifically, the results of first-line therapy with a tyrosine-kinase inhibitor (TKI) followed by second-line therapy with different TKI and first-line TKI with a switch to a Mammalian Target of Rapamycin (mTOR) inhibitor have been evaluated. At this time, no studies have been conducted to evaluate the real-world use of pazopanib in aRCC patients treated in with first-line pazopanib then switched to an mTOR inhibitor (temsirolimus or everolimus). The objectives of this study are to assess the patient characteristics, clinical and safety outcomes, treatment patterns, and healthcare resource use (HCRU) associated with (i) aRCC patients treated with pazopanib as first-line therapy and (ii) progressive aRCC patients first treated with pazopanib followed by treatment with an mTOR inhibitor in a community oncology setting in the United States (US). This is a descriptive study; therefore no hypotheses will be tested.Data will be extracted from the McKesson Specialty Health/US Oncology Network database, which includes data from iKnowMed (iKM), Claims Data Warehouse (CDW), Social Security Death Index (SSDI), and medical record reviews.This study design will be a descriptive, retrospective, and longitudinal analysis and medical records review of eligible subjects.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Time to Treatment Failure (TTTF)
Timeframe: 3 years
Progression-Free Survival (PFS)
Timeframe: 3 years
Time to Brain Metastasis (TTBM)
Timeframe: 3 years
Overall survival
Timeframe: 3 years
Adverse events (AEs)
Timeframe: 3 years
Secondary outcomes:
Health Care Resource Utilization
Timeframe: 3 years
Treatment and Utilization Patterns
Timeframe: 3 years
Interventions:
Enrollment:
0
Primary completion date:
2014-17-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Vogelzang N, Hackshaw M, Hutson T, et al.First-line and Sequential Use of Pazopanib Followed by mTOR Inhibitor Therapy Among Patients with Advanced Renal Cell Carcinoma in a US Community Oncology Setting.Clinical Genitourinary Cancer.2015;13(3):210-217
- All subjects with a diagnosis search term of ’Renal Cell Carcinoma’ in the iKM database and were diagnosed at stage III/IV or were diagnosed at early stage but developed metastatic disease
- Subjects who received pazopanib (Cohorts I and II) as first line of therapy in the defined study period.
- Subjects enrolled in a clinical trial.
- Subjects diagnosed with and treated for major cancers other than RCC.
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects with a diagnosis search term of ’Renal Cell Carcinoma’ in the iKM database and were diagnosed at stage III/IV or were diagnosed at early stage but developed metastatic disease
- Subjects who received pazopanib (Cohorts I and II) as first line of therapy in the defined study period.
- Subjects with 2 or more visits within the US Oncology Network.
- Subjects at least 18 years of age at first diagnosis of RCC.
Exclusion criteria:
- Subjects enrolled in a clinical trial.
- Subjects diagnosed with and treated for major cancers other than RCC.
- Subjects who are diagnosed with RCC but started first-line treatment with pazopanib beyond the study period.
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
2014-17-03
Actual study completion date
2014-17-03
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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