Last updated: 02/04/2020 15:30:06
Persistence and Compliance among United States Patients Receiving Pazopanib or Sunitinib as First-Line Therapy for Advanced Renal Cell Carcinoma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Persistence and Compliance among United States Patients Receiving Pazopanib or Sunitinib as First‐Line Therapy for Advanced Renal Cell Carcinoma
Trial description: Randomized controlled clinical trials have demonstrated that pazopanib and sunitinib are safe and effective treatments when used as first‐line therapy for advanced renal cell carcinoma (RCC). An understanding of the treatment and utilization patterns associated with these drugs outside of a controlled setting will be useful to decision makers. The study will assess and compare persistence and compliance among patients who receive pazopanib versus sunitinib as first‐line therapy for advanced RCC. Persistence with treatment is defined as the duration of time from therapy initiation to discontinuation. Compliance refers to the consistency and accuracy of the prescribed drug treatment regimen. The primary objectives of this study are to estimate and compare medication persistence and compliance among matched subjects who initiate first‐line therapy with pazopanib or sunitinib for the management of advanced RCC. The null hypotheses are that persistence with first‐line pazopanib will not differ from first-line sunitinib, and that compliance with first-line pazopanib will not differ from first-line sunitinib. The test hypotheses are that persistence with first‐line pazopanib will be greater than with first-line sunitinib and that compliance with first-line pazopanib will be greater than with first-line sunitinib.The secondary objectives are to describe and compare clinical outcomes, such as adverse events and mortality, and treatment patterns among advanced RCC patients who receive pazopanib versus sunitinib as first‐line therapy. The study is a comparative study employing a retrospective, cohort design.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Compliance - Medication Possession Ratio (MPR)
Timeframe: 6 months
Persistance
Timeframe: 6 months
Secondary outcomes:
Adverse Events
Timeframe: 6 months
Survival
Timeframe: 6 months
Initiation of a new drug
Timeframe: 6 months
Dosing
Timeframe: 6 months
Interventions:
Enrollment:
0
Primary completion date:
2014-21-02
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
DaCosta Byfield S, McPheeters J, Burton T, Nagar S, Hackshaw M.Persistence and Compliance among US Patients Receiving Pazopanib or Sunitinib as First-Line Therapy for Advanced Renal Cell Carcinoma: A Retrospective Claims Analysis.J Manag Care Spec Pharm.2015;21(6):515-22
- Evidence of RCC: At least 2 diagnosis claims with a primary diagnosis code for RCC at least 30 days apart, between 01 April 2009 and 30 June 2012 identified by International Classification of Disease, Ninth Revision, Clinical Modification (ICD‐9‐CM) code 189.0 and/or 189.1
- Evidence of Advanced RCC: At least 2 claims with a diagnosis of advanced or metastatic disease (ICD‐9‐CM 196.xx‐199.xx), at least 30 days apart, in any position on the claim between 01 October 2009 and 30 June 2012
- Multiple tumors: Subjects with medical claims for another primary cancer that is not associated with common RCC metastatic sites (i.e. lung ICD‐9‐CM 162.xx, bone 170.xx, brain 191.xx, liver 155,xx) during the study period
- Dual therapy: Subjects with claims for both pazopanib and sunitinib on the index date will be excluded from the study sample.
Inclusion and exclusion criteria
Inclusion criteria:
- Evidence of RCC: At least 2 diagnosis claims with a primary diagnosis code for RCC at least 30 days apart, between 01 April 2009 and 30 June 2012 identified by International Classification of Disease, Ninth Revision, Clinical Modification (ICD‐9‐CM) code 189.0 and/or 189.1
- Evidence of Advanced RCC: At least 2 claims with a diagnosis of advanced or metastatic disease (ICD‐9‐CM 196.xx‐199.xx), at least 30 days apart, in any position on the claim between 01 October 2009 and 30 June 2012
- Evidence of First‐line Therapy: At least 1 pharmacy claim for pazopanib or sunitinib on or after the date of the first advanced RCC diagnosis
- Continuous Enrollment: Continuously enrolled in the health plan with medical and pharmacy benefits for 6 months without a gap before the index date (baseline period) and at least 6 months after the index date (follow‐up period). Patients who disenroll with less than 6 months of follow‐up due to death will be identified but not retained in the study sample.
- Treatment‐naïve: No evidence of immunomodulator or molecular‐targeted therapy during 6‐month baseline.
- Age: At least 18 years of age on the index date.
Exclusion criteria:
- Multiple tumors: Subjects with medical claims for another primary cancer that is not associated with common RCC metastatic sites (i.e. lung ICD‐9‐CM 162.xx, bone 170.xx, brain 191.xx, liver 155,xx) during the study period
- Dual therapy: Subjects with claims for both pazopanib and sunitinib on the index date will be excluded from the study sample.
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
2014-21-02
Actual study completion date
2014-21-02
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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