Last updated: 11/07/2018 11:43:26
Meta-Analysis of Liver Chemistry Abnormalities with GW786034 (Pazopanib) Treatment in Advanced/Metastatic Renal Cell Carcinoma, Soft Tissue Sarcoma and Ovarian Cancer
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Meta-Analysis of Liver Chemistry Abnormalities with GW786034 (Pazopanib) Treatment in Advanced/Metastatic Renal Cell Carcinoma, Soft Tissue Sarcoma and Ovarian Cancer
Trial description: The purpose of this meta-analysis was to evaluate the incidence, time course, outcome, re-challenge and pattern of pazopanib-induced liver events, as well as potential predictive factors, in order to provide further guidance to treating physicians.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
• Characterisation of ALT elevations with clinical symptoms
Timeframe: Retrospective
• Clinical adjudication and characterisation of cases with concurrent ALT > 3xULN and total bilirubin ≥ 2xULN to identify those meeting Hy’s Law and cases of ALT > 20xULN
Timeframe: Retrospective
• Characterisation of the pattern of liver laboratory abnormalities
Timeframe: Retrospective
• Characterisation of the incidence, time course and outcome of on-therapy liver laboratory abnormalities (defined as ALT > 3xULN)
Timeframe: Retrospective
Summary of All Treated Population
Timeframe: Retrospective
• Multivariate analysis for predictive and prognostic factors associated with ALT elevations > 3, > 5 and > 8xULN
Timeframe: Retrospective
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
2080
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Powles T, Bracarda S, Chen M, Norry E, Compton N, Heise M, Carpenter C, Pandite L, Hutson T, Harter P, Kaplowitz N. RESUBMISSION Characterization of Liver Chemistry Abnormalities Associated with Pazopanib Monotherapy: A Systematic Review and Meta-Analysis of Clinical Trials in Advanced Cancer Patients. Eur J Cancer. 2015;51(10):1293-302
Medical condition
Cancer, Neoplasms
Product
pazopanib
Collaborators
Not applicable
Study date(s)
October 2013 to December 2013
Type
Observational
Phase
2/3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Subject participation in one of the studies included in the meta-analysis.
- Subject was not a participant in one of the studies included in the meta-analysis
Inclusion and exclusion criteria
Inclusion criteria:
- Subject participation in one of the studies included in the meta-analysis.
Exclusion criteria:
- Subject was not a participant in one of the studies included in the meta-analysis
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
Not applicable
Actual study completion date
2013-05-12
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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