Last updated: 02/04/2020 16:00:15
Meta-Analysis Plan for liver analyses with GW786034 (pazopanib) treatment in advanced/metastatic renal cell carcinoma and soft tissue sarcoma to support a regulatory post marketing requirement
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Meta-Analysis Plan for liver analyses with GW786034 (pazopanib) treatment in advanced/metastatic renal cell carcinoma and soft tissue sarcoma to support a regulatory post marketing requirement
Trial description: An integrated analysis of the data from pazopanib studies in renal cell carcinoma and soft tissue sarcoma. This analysis is intended to fulfill a post marketing requirement to examine the safety of dose modification of pazopanib and patient rechallenge with pazopanib following hepatoxicity. The analysis will include at least 1500 subjects from VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG20002 and VEG110727.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Liver safety profile
Timeframe: N/A
Secondary outcomes:
Not applicable
Interventions:
Drug: Pazopanib
Enrollment:
0
Observational study model:
Other
Primary completion date:
2013-23-05
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Sarcoma, Soft tissue, Carcinoma, Renal Cell
Product
pazopanib
Collaborators
Not applicable
Study date(s)
April 2013 to May 2013
Type
Observational
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 999 Year
Accepts healthy volunteers
none
- Subjects who have participated on VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG200002, or VEG110727
- Subjects received pazopanib therapy while on the above trials
- Not having received pazopanib on one of the aforementioned trials.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who have participated on VEG102616, VEG105192, VEG107769, VEG108844, VEG113078, VEG200002, or VEG110727
- Subjects received pazopanib therapy while on the above trials
Exclusion criteria:
- Not having received pazopanib on one of the aforementioned trials.
Trial location(s)
No location data available.
Study documents
Statistical analysis plan
Available language(s): English
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
Finalized
Actual primary completion date
2013-23-05
Actual study completion date
2013-23-05
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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