Last updated: 11/03/2018 20:37:21
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
A Retrospective Medical Records Review of patients receiving pazopanib therapy for advanced RCC at the Christie Hospital
GSK study ID
200111
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Retrospective Medical Records Review of patients receiving pazopanib therapy for advanced RCC at the Christie Hospital
Trial description: A retrospective open-cohort observational study using real-life medical records data from the Christie. Medical records for aRCC patients having received pazopanib will be reviewed by centre staff with respect to treatment patterns, efficacy, safety, and medical resource utilisation. This is a non-experimental study and no treatments will be provided to patients as part of this study. The study population of interest is treatment-naïve patients with RCC. The observation period for each patient will extend from initiation of pazopanib therapy to the earliest of last treatment date +3 months, death, loss to follow-up, or end of the study period (dependent on start of data collection). The results for pazopanib therapy will be compared with historical data from the respective clinical trials if comparable data are available and it is statistically appropriate.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Progression free survival
Timeframe: Until death or progression
Secondary outcomes:
Safety measures
Timeframe: Until death or discontinuation of treatment
Overall survival
Timeframe: Until death
Tolerability
Timeframe: Until death or discontinuation of treatment
Overall response rate
Timeframe: Until death or discontinuation of treatment
Interventions:
Enrollment:
104
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
December 2012 to August 2015
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Aged 18 years and older
- Actively treated at the participating centre (to avoid incomplete data)
- Patients having no pazopanib therapy that started at least 3 months prior to chart abstraction (to ensure a sufficient observation period)
- Patients receiving 2nd line pazopanib following progression on anti-VEGF therapy
Inclusion and exclusion criteria
Inclusion criteria:
- Aged 18 years and older
- Actively treated at the participating centre (to avoid incomplete data)
- Patients receiving at least one administration or dose of pazopanib 1st line advanced RCC (including those patients who have received first-line sunitinib who have switched to pazopanib due to toxicity i.e. have not progressed and are therefore still considered 1st line)
- 2nd line advanced RCC following previous IL-2/IFN
- Clear cell histology
Exclusion criteria:
- Patients having no pazopanib therapy that started at least 3 months prior to chart abstraction (to ensure a sufficient observation period)
- Patients receiving 2nd line pazopanib following progression on anti-VEGF therapy
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
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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