Status:
COMPLETED
A Study To Test The Effect Of GW786034 (Pazopanib) On P450 Enzymes
Lead Sponsor:
GlaxoSmithKline
Conditions:
Carcinoma, Renal Cell
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
July 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00401583
Start Date
July 28 2006
End Date
February 20 2008
Last Update
November 13 2017
Active Locations (2)
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1
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
2
GSK Investigational Site
Singapore, Singapore, 119074