A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer
Cancer cells need to be able to make new blood vessels in order to keep growing. This is called angiogenesis. In a laboratory setting, the drug itraconazole was shown to help stop the growth of new blood vessels (anti-angiogenesis). It is hoped that itraconazole will prevent new blood vessels from forming in humans too.
The purpose of this study is to look at how the body processes and breaks down itraconazole (called pharmacokinetics). This study will also measure markers in your blood to see if itraconazole stops new blood vessels from forming. The safety of itraconazole will also be tested to see what effects (good and bad) it has on you and your breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Itraconazole Pharmacokinetics in Patients With Metastatic Breast Cancer|
- To determine the pharmacokinetics (PK) of oral itraconazole in patients with MBC by measuring trough plasma levels at steady state and to correlate measures of angiogenesis with plasma levels of itraconazole and its active metabolite hydroxyitraconazole. [ Time Frame: Baseline through week 4 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||February 2014|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Patients will receive oral itraconazole 200mg a day until disease progression.
oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798135
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kathy Miller, MD||Indiana University Melvin and Bren Simon Cancer Center|