A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes

Completed · Phase 1

Conditions studied: Carcinoma, Renal Cell

In brief

This is a Phase I study to determine the effect of GW786034 (pazopanib) on P450 enzymes. This study will help determine which types of drugs may interact with GW786034.

Key facts

Study ID

NCT00401583

Run by

GlaxoSmithKline

People needed

24

Starts

2006-07-28

Expected to finish

2008-02-20

Last updated by the study team

2017-11-13

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of advanced solid tumors.
• 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

You may not qualify if…

• Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days.
• 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.

Where it is running

• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Singapore, Singapore

Full record on ClinicalTrials.gov

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