Last updated: 11/03/2018 20:45:56
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.
Drug Use Investigation of VOTRIENT® Tablets (Investigation in Patients with Renal Cell Carcinoma)
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: Drug Use Investigation of VOTRIENT® Tablets (Investigation in Patients with Renal Cell Carcinoma)
Trial description: This investigation will be conducted to collect and assess information regarding the safety and effectiveness of pazopanib tablets in patients with renal cell carcinoma (RCC) in routine clinical practice. VOTRIENT is a registered trademark of the GSK Group of Companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Overall survival
Timeframe: 1 year
Occurrence of adverse drug reactions (ADRs) and infections
Timeframe: 1 year
Occurrence of ADRs when dose is increased following dose reduction
Timeframe: 1 year
Response rate
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Drug: Pazopanib
Enrollment:
150
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
August 2014 to February 2018
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients who were diagnosed as having unresectable or metastatic RCC
- Patients who are treated with pazopanib for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients who were diagnosed as having unresectable or metastatic RCC
- Patients who are treated with pazopanib for the first time
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
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
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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