A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes
NCT ID: NCT00401583
Last Updated: 2017-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2006-07-28
2008-02-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pazopanib receivers
During Days 1 and 2 subjects will be dosed with only probe drugs, and with no drugs on Days 3-5. During Days 6 to the end of the study, subjects will receive 800 mg daily pazopanib, and on Days 23-24 subjects will receive probe drugs in addition to pazopanib
GW786034 (pazopanib)
Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
Probe drugs
probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).
Interventions
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GW786034 (pazopanib)
Pazopanib will be given as monohydrochloride, 100 and 500 mg tablets.
Probe drugs
probe drugs will be oral midazolam (3 mg), warfarin (10 mg), omeprazole (40 mg), caffeine (200 mg), and dextromethorphan (30 mg).
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow, renal, lung, and liver function.
* A female subject must not be pregnant and will agree not to become pregnant during the trial
Exclusion Criteria
* Poorly controlled hypertension.
* Corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 480 msec and a prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities.
* Arterial or venous thrombi (including cerebrovascular accident), myocardial infarction, admission for unstable angina, cardiac angioplasty, or stenting within the last 3 months.
* Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents).
Amiodarone must not have been taken for at least 6 months prior to the administration of the first dose of study drug.
* History of brain metastases.
* Has narrow-angle glaucoma which is a contraindication to midazolam use.
* History of nicotine-containing product (including cigarettes, cigars, nicotine patches) use within the past 6 months.
* A history of bleeding problems.
21 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Lebanon, New Hampshire, United States
GSK Investigational Site
Singapore, , Singapore
Countries
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References
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Goh BC, Reddy NJ, Dandamudi UB, Laubscher KH, Peckham T, Hodge JP, Suttle AB, Arumugham T, Xu Y, Xu CF, Lager J, Dar MM, Lewis LD. An evaluation of the drug interaction potential of pazopanib, an oral vascular endothelial growth factor receptor tyrosine kinase inhibitor, using a modified Cooperstown 5+1 cocktail in patients with advanced solid tumors. Clin Pharmacol Ther. 2010 Nov;88(5):652-9. doi: 10.1038/clpt.2010.158. Epub 2010 Sep 29.
Other Identifiers
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VEG10007
Identifier Type: -
Identifier Source: org_study_id