Status:
COMPLETED
Hepatic Monitoring for Pazopanib
Lead Sponsor:
GlaxoSmithKline
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
18+ years
Brief Summary
Pazopanib is approved by the FDA and EMA as targeted therapy for the indication of advanced renal cell carcinoma (RCC). Hepatic safety events were observed in the pazopanib pivotal clinical trial and ...
Eligibility Criteria
Inclusion
- In the prescriber compliance analysis, all adult (18+ years) new users of pazopanib with an indication of RCC will be eligible for the analysis.
- In the liver enzyme elevation analysis, all adult (18+ years) new users of pazopanib, sunitinib, bevacizumab, and sorafenib in monotherapy for any cancer type who have a baseline liver enzyme value will be eligible for the analysis.
- In the drug-induced liver injury analyses, all adult (18+ years) new users of pazopanib, sunitinib, bevacizumab, and sorafenib with RCC (as defined by ICD-9 codes) will be longitudinally followed up in order to capture occurrences of liver enzyme elevations consistent with Hy's Law and ICD-9 codes indicative of possible ALF to evaluate for drug-induced liver injury.
Exclusion
- N/A
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01449825
Start Date
December 1 2010
End Date
December 1 2013
Last Update
April 21 2014
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