VEG113971: An Open-Label Study of the Effects of Ketoconazole or Esomeprazole on Pazopanib PK
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2010 |
| End Date: | February 2012 |
An Open-Label Study to Evaluate the Effects of Ketoconazole and the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Repeat Doses of Pazopanib in Subjects With Solid Tumor Malignancies
The purpose of this study is to determine how dosing with ketoconazole (Nizoral) or
esomeprazole (Nexium) affects the pharmacokinetics of oral pazopanib. The study will also
test for safety of pazopanib when administered with ketoconazole or esomeprazole.
The study is a 2-arm, open-label, repeat-dose, single sequence, crossover, study designed to
evaluate the effects of ketoconazole (Arm A) and esomeprazole (Arm B) on the
pharmacokinetics (PK) of oral pazopanib in subjects with solid tumor malignancies. This
study will compare the PK parameters of oral pazopanib and its metabolite concentrations
when given alone and when co-administered with either ketoconazole (Arm A) or esomeprazole
(Arm B). Safety assessments (physical examinations, vital signs, 12-lead
electrocardiograms, Eastern Cooperative Oncology Group performance status, clinical
laboratory assessments, and monitoring of adverse events) will also be evaluated during the
study.
We found this trial at
2
sites
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